Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption, 83417 [2023-26250]
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83417
Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Notices
3. The date the application was
approved: July 9, 2021. FDA has verified
the applicant’s claim that NDA 215341
was approved on July 9, 2021.
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 1,597 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
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 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
[FR Doc. 2023–26251 Filed 11–28–23; 8:45 am]
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food and Drug Administration
State Petitions for Exemption From
Preemption
BILLING CODE 4164–01–P
[Docket No. FDA–2023–N–2707]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 December
29, 2023.
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
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 0910–0277. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
SUMMARY:
OMB Control Number 0910–0277—
Extension
This information collection supports
FDA regulations. Under section 403A(b)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 343–1(b)),
States may petition FDA for exemption
from Federal preemption of State food
labeling and standard-of-identity
requirements. Section 100.1(c) (21 CFR
100.1(c)) provides prerequisites a
petition must satisfy for an exemption
from preemption. Section 100.1(d) sets
forth the information a State is required
to submit in such a petition. The
petition must be submitted to the
Dockets Management Staff. The
information required under § 100.1
enables FDA to determine whether the
State food labeling or standard-ofidentity requirement satisfies the
criteria of section 403A(b) of the FD&C
Act for granting exemption from Federal
preemption.
In the Federal Register of July 31,
2023 (88 FR 49469), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four information collection topics
solicited.
Description of Respondents: The
respondents to this collection of
information are State and local
governments who regulate food labeling
and standards-of-identity.
We estimate the burden of this
collection of information as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.1; petition for exemption from preemption ....................
1
1
1
40
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1 is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the next 3 years,
we estimate that one or fewer petitions
will be submitted annually.
VerDate Sep<11>2014
17:26 Nov 28, 2023
Jkt 262001
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
PO 00000
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26250 Filed 11–28–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Page 83417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26250]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2707]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Petitions for
Exemption From Preemption
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 December 29, 2023.
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
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 0910-0277. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
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.
State Petitions for Exemption From Preemption
OMB Control Number 0910-0277--Extension
This information collection supports FDA regulations. Under section
403A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 343-1(b)), States may petition FDA for exemption from Federal
preemption of State food labeling and standard-of-identity
requirements. Section 100.1(c) (21 CFR 100.1(c)) provides prerequisites
a petition must satisfy for an exemption from preemption. Section
100.1(d) sets forth the information a State is required to submit in
such a petition. The petition must be submitted to the Dockets
Management Staff. The information required under Sec. 100.1 enables
FDA to determine whether the State food labeling or standard-of-
identity requirement satisfies the criteria of section 403A(b) of the
FD&C Act for granting exemption from Federal preemption.
In the Federal Register of July 31, 2023 (88 FR 49469), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four information collection topics solicited.
Description of Respondents: The respondents to this collection of
information are State and local governments who regulate food labeling
and standards-of-identity.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1; petition for exemption from preemption...................... 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for Sec. 100.1 is minimal because petitions
for exemption from preemption are seldom submitted by States. In the
next 3 years, we estimate that one or fewer petitions will be submitted
annually.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26250 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P
