Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 30952 [2021-12156]
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30952
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
drug application became effective was
on December 29, 2009.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): April 30, 2019. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
SARCLISA (BLA 761113) was initially
submitted on April 30, 2019.
3. The date the application was
approved: March 2, 2020. FDA has
verified the applicant’s claim that BLA
761113 was approved on March 2, 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 applications for patent extension,
this applicant seeks 86 or 1,596 days of
patent term extension.
khammond on DSKJM1Z7X2PROD with NOTICES
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
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: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12189 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1031, FDA–
2013–N–0878, FDA–2014–N–0998, FDA–
2014–N–1076, FDA–2013–N–0520, FDA–
2017–N–6397, FDA–2014–N–1030, and FDA–
2020–N–1228]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—
Continued
Title of collection
Formal Dispute
Resolution; Scientific and
Technical
Issues Related
to Pharmaceutical Current
Good Manufacturing Practice ..
Substances Prohibited From
Use in Animal
Food or Feed ...
Food Labeling;
Calorie Labeling
of Articles of
Food in Vending
Machines and
Nutrition Labeling of Standard
Menu Items in
Restaurants and
Similar Retail
Food Establishments ...............
Food Allergen Labeling and Reporting ..............
Study of Multiple
Indications in
Direct-to-Consumer Television Advertisements ...............
FDA recall regulations .................
Premarket Notification for a New
Dietary Ingredient .................
Regulations for In
Vivo Radiopharmaceuticals
Used for Diagnosis and Monitoring ................
PO 00000
Frm 00043
OMB
control
number
5/31/2024
0910–0330
5/31/2024
0910–0409
5/31/2024
Fmt 4703
Sfmt 4703
0910–0563
5/31/2024
0910–0627
5/31/2024
0910–0782
5/31/2024
0910–0792
5/31/2024
0910–0897
5/31/2024
Dated: June 4, 2021.
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12156 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
Date
approval
expires
0910–0249
Date
approval
expires
Lauren K. Roth,
TABLE 1—LIST OF INFORMATION
COLLECTIONS APPROVED BY OMB
Title of collection
OMB
control
number
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12156]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-N-1031, FDA-2013-N-0878, FDA-2014-N-0998, FDA-
2014-N-1076, FDA-2013-N-0520, FDA-2017-N-6397, FDA-2014-N-1030, and
FDA-2020-N-1228]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, Health and Human Services (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, 10A-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
------------------------------------------------------------------------
FDA recall regulations.................. 0910-0249 5/31/2024
Premarket Notification for a New Dietary 0910-0330 5/31/2024
Ingredient.............................
Regulations for In Vivo 0910-0409 5/31/2024
Radiopharmaceuticals Used for Diagnosis
and Monitoring.........................
Formal Dispute Resolution; Scientific 0910-0563 5/31/2024
and Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice.................
Substances Prohibited From Use in Animal 0910-0627 5/31/2024
Food or Feed...........................
Food Labeling; Calorie Labeling of 0910-0782 5/31/2024
Articles of Food in Vending Machines
and Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments....................
Food Allergen Labeling and Reporting.... 0910-0792 5/31/2024
Study of Multiple Indications in Direct- 0910-0897 5/31/2024
to-Consumer Television Advertisements..
------------------------------------------------------------------------
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12156 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
