60-Day FRN

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Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices

determining this patent’s eligibility for
patent term restoration. In a letter dated
December 14, 2020, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
ZEPZELCA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.

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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ZEPZELCA is 4,170 days. Of this time,
3,987 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: January 16, 2009. The
applicant claims January 14, 2009, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 16, 2009,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
new drug application under section 505
of the Federal Food, Drug, and Cosmetic
Act: December 16, 2019. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
ZEPZELCA (NDA 213702) was initially
submitted on December 16, 2019.
3. The date the application was
approved: June 15, 2020. FDA has
verified the applicant’s claim that NDA
213702 was approved on June 15, 2020.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must

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comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26009 Filed 11–29–21; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Certificate of Origin (CBP Form 3229)
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:

The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
must be submitted (no later than
January 31, 2022) to be assured of
consideration.
SUMMARY:

Written comments and/or
suggestions regarding the item(s)
contained in this notice must include
the OMB Control Number 1651–0016 in
the subject line and the agency name.
Please use the following method to
submit comments:
Email. Submit comments to: CBP_
[email protected].
Due to COVID–19-related restrictions,
CBP has temporarily suspended its

ADDRESSES:

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ability to receive public comments by
mail.
FOR FURTHER INFORMATION CONTACT:
Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177, telephone
number 202–325–0056, or via email
[email protected]. Please note that
the contact information provided here is
solely for questions regarding this
notice. Individuals seeking information
about other CBP programs should
contact the CBP National Customer
Service Center at 877–227–5511, (TTY)
1–800–877–8339, or CBP website at
https://www.cbp.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.
Overview of This Information
Collection
Title: Certificate of Origin.
OMB Number: 1651–0016.
Form Number: CBP Form 3229.
Current Actions: Extension without
change.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Abstract: CBP Form 3229, Certificate
of Origin, is used by shippers and

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Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
importers to declare that goods being
imported into the United States are
grown or the product of an insular
possession of the United States and/or
produced or manufactured in a U.S.
insular possession from material grown
in or product of such possession. This
form includes a list of the foreign
materials in the goods, including their
description and value. CBP Form 3229
is used as documentation for goods
entitled to enter the U.S. free of duty.
This form is authorized by General Note
3(a)(iv) of the Harmonized Tariff
Schedule of the United States (19 U.S.C.
1202) and is provided for by 19 CFR
part 7.3. CBP Form 3229 is accessible at:
https://www.cbp.gov/newsroom/
publications/forms?title=3229&=Apply.
Type of Information Collection:
Certificate of Origin (CBP Form 3229).
Estimated Number of Respondents:
113.
Estimated Number of Annual
Responses per Respondent: 20.
Estimated Number of Total Annual
Responses: 2,260.
Estimated Time per Response: 20
minutes.
Estimated Total Annual Burden
Hours: 753.
Dated: November 23, 2021.
Robert F. Altneu,
Director, Regulations & Disclosure Law
Division, U.S. Customs and Border Protection.
[FR Doc. 2021–25997 Filed 11–29–21; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0100]

Petition for Remission or Mitigation of
Forfeitures and Penalties Incurred
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:

The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
must be submitted (no later than

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SUMMARY:

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67963

January 31, 2022) to be assured of
consideration.

for approval. All comments will become
a matter of public record.

Written comments and/or
suggestions regarding the item(s)
contained in this notice must include
the OMB Control Number 1651–0100 in
the subject line and the agency name.
Please use the following method to
submit comments:
Email. Submit comments to: CBP_
[email protected].
Due to COVID–19-related restrictions,
CBP has temporarily suspended its
ability to receive public comments by
mail.

Overview of This Information
Collection

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177, telephone
number 202–325–0056, or via email
[email protected]. Please note that
the contact information provided here is
solely for questions regarding this
notice. Individuals seeking information
about other CBP programs should
contact the CBP National Customer
Service Center at 877–227–5511, (TTY)
1–800–877–8339, or CBP website at
https://www.cbp.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request

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Title: Petition for Remission or
Mitigation of Forfeitures and Penalties
Incurred.
OMB Number: 1651–0100.
Form Number: CBP Form 4609.
Current Actions: Extension without
change.
Type of Review: Extension (without
change).
Affected Public: Individuals and
Businesses.
Abstract: CBP Form 4609, Petition for
Remission of Forfeitures and Penalties
Incurred, is completed, and filed with
the CBP FP&F Officer designated in the
notice of claim by individuals who have
been found to be in violation of one or
more provisions of the Tariff Act of
1930, or other laws administered by
CBP. Persons who violate the Tariff Act
of 1930, or other laws administered by
CBP, are entitled to file a petition
seeking remission or mitigation of a
fine, penalty, or forfeiture incurred
under these laws. This petition is
submitted on CBP Form 4609. The
information provided on this form is
used by CBP personnel as a basis for
granting relief from forfeiture or penalty.
CBP Form 4609 is authorized by 19
U.S.C. 1618 and provided for by 19 CFR
171.1. It is accessible at https://
www.cbp.gov/newsroom/publications/
forms?title=4609.
This collection of information applies
to members of the public who may not
be familiar with import procedures and
CBP regulations. It may also be used by
the importing and trade community
who are familiar with import
procedures and with the CBP
regulations.
Type of Information Collection: CBP
Form 4609.
Estimated Number of Respondents:
1,610.
Estimated Number of Annual
Responses per Respondent: 1.
Estimated Number of Total Annual
Responses: 1,610.
Estimated Time per Response: 14
minutes.
Estimated Total Annual Burden
Hours: 376.
Dated: November 23, 2021.
Robert F. Altneu,
Director, Regulations & Disclosure Law
Division, U.S. Customs and Border Protection.
[FR Doc. 2021–25998 Filed 11–29–21; 8:45 am]
BILLING CODE P

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