Determination That NAROPIN (Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 71871-71872 [2023-22960]
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Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices
https://www.acl.gov/about-acl/publicinput.
In accordance with the PRA 44 U.S.C.
3506(c)(2)(A); 44 U.S.C. 3507(a)(1)(D)
ACL details the proposed Gen IC
pertaining to:
• the method of collection;
• the category (or categories) of
respondents;
• the estimated maximum number of
burden hours (per year) for the specific
information collections, and against
which burden will be charged for each
collection actually used;
• ACL’s plans for how it will use the
information collected; and
• ACL’s internal procedures to ensure
that the specific collections comply
with the PRA, applicable regulations,
and the terms of the generic clearance.
Estimated Program Burden: ACL
estimates the burden of this collection
of information as follows:
ESTIMATED ANNUALIZED BURDEN TABLE
Respondent/data collection activity
State
State
State
State
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Unit on Aging (SUA) ................
Entity for APS ..........................
Entity for APS ..........................
Unit on Aging (SUA) ................
State Plan on Aging .........................
State Plan on APS ...........................
Required Assurances for APS (4) ...
Financial Forms ................................
14.7
56
56
56
1
1
3
5
80
6
10
1
1,176
336
1,680
280
Total Estimated Burden .............
...........................................................
........................
........................
........................
3,472
Dated: October 12, 2023.
Alison Barkoff,
Senior official performing the duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2023–22956 Filed 10–17–23; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–1323]
Determination That NAROPIN
(Ropivacaine Hydrochloride) Solution,
50 Milligrams/10 Milliliters and 75
Milligrams/10 Milliliters, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that Naropin
(ropivacaine hydrochloride) solution, 50
milligrams (mg)/10 milliliters (mL) and
75mg/10mL, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to these drug products as long as
they meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Alexander Poonai, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
respondents
Form
VerDate Sep<11>2014
18:01 Oct 17, 2023
Jkt 262001
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–3600, Alexander.Poonai@
fda.hhs.gov.
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Naropin (ropivacaine hydrochloride)
solution, 50mg/10mL and 75mg/10mL,
are the subject of NDA 020533, held by
Fresenius Kabi USA LLC, and initially
approved on May 1, 1998. Naropin is
indicated for the production of local or
regional anesthesia for surgery and for
acute pain management.
Naropin (ropivacaine hydrochloride)
solution, 50mg/10mL and 75mg/10mL,
are currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated
December 15, 2021 (Docket No. FDA–
2021–P–1323), under 21 CFR 10.30,
requesting that the Agency determine
whether Naropin (ropivacaine
hydrochloride) solution, 50mg/10mL
and 75mg/10mL, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that Naropin (ropivacaine
hydrochloride) solution, 50mg/10mL
and 75mg/10mL, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that these
drug products were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
Naropin (ropivacaine hydrochloride)
solution, 50mg/10mL and 75mg/10mL,
from sale. We have also independently
E:\FR\FM\18OCN1.SGM
18OCN1
71872
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that these
drug products were not withdrawn from
sale for reasons of safety or
effectiveness.
Accordingly, the Agency will
continue to list Naropin (ropivacaine
hydrochloride) solution, 50mg/10mL
and 75mg/10mL, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to Naropin
(ropivacaine hydrochloride) solution,
50mg/10mL and 75mg/10mL, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22960 Filed 10–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2986]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 November
17, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:01 Oct 17, 2023
Jkt 262001
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 0910–0216. 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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Color Additive Certification
OMB Control Number 0910–0216—
Extension
This information collection supports
FDA regulations governing certification
for color additives used in foods, drugs,
cosmetics, and medical devices. All
color additives must have FDA-approval
for their intended use and be listed in
the color additive regulations before
they are permitted for use in food,
drugs, cosmetics, and many medical
devices. Some color additives have an
additional requirement: they are
permitted only if they are from batches
that FDA has certified under section
721(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379e(a)). This
means that FDA chemists have analyzed
a sample from the batch and have found
that it meets the requirements for
composition and purity stated in the
regulation, called a ‘‘listing regulation,’’
for that color additive. We list color
additives that have been shown to be
safe for their intended uses in Title 21
of the Code of Federal Regulations
(CFR). We require batch certification for
all color additives listed in 21 CFR part
74 and for all color additives
provisionally listed in 21 CFR part 82.
Color additives listed in 21 CFR part 73
are exempted from certification.
The requirements for color additive
certification are established in 21 CFR
part 80. Procedures for color additive
certification are set forth in part 80,
subpart B (§§ 80.21 through 80.39) and
communicate required data elements for
requests for certification, limitations of
certificates, exemptions from
certification for color additive mixtures,
treatment of batches pending and after
certification, and recordkeeping
requirements for respondents to whom
a certificate is issued. During the batch
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
certification procedure, a manufacturer
of color additives must submit a
‘‘request for certification’’ that provides
information about the batch,
accompanied by a representative sample
of a new batch of color additive, to
FDA’s Office of Cosmetics and Colors.
FDA personnel perform chemical and
other analyses of the representative
sample and, providing the sample
satisfies all certification requirements,
issue a certificate that contains a
certification lot number for the batch.
The batch can then be used in FDAregulated products marketed in the
United States, in compliance with the
uses and restrictions in that color
additive’s listing regulation. If the
sample does not meet the requirements,
the batch will be rejected. We require
manufacturers to keep complete records
showing disposal of all of the color
additive covered by the certification.
FDA’s web-based color certification
information system is available for
respondents to request color
certification online, track their
submissions, and obtain account status
information. Prior to submitting a
request for certification, the
manufacturer must open a color
certification account by sending a letter,
as an email attachment, signed by
responsible company representative, to
FDA’s Office of Cosmetics and Colors at
color.cert@fda.hhs.gov. System
certification results are returned
electronically, allowing submitters to
sell their certified color before receiving
hard copy certificates.
We charge a fee for certification based
on the batch weight and require
manufacturers to keep records of the
batch pending and after certification.
The user fees support FDA’s color
certification program. Additional
information about color additive
certification is available at: https://
www.fda.gov/industry/color-additives/
color-certification.
The purpose for collecting this
information is to help the Agency assure
that only safe color additives will be
used in foods, drugs, cosmetics, and
medical devices sold in the United
States.
Description of Respondents: The
respondents include businesses engaged
in the manufacture of color additives
used in FDA-regulated foods, drugs,
cosmetics, and medical devices.
Respondents are from the private sector
(for-profit businesses).
In the Federal Register of August 10,
2023 (88 FR 54329), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
E:\FR\FM\18OCN1.SGM
18OCN1
]]>Agencies
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71871-71872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-1323]
Determination That NAROPIN (Ropivacaine Hydrochloride) Solution,
50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that Naropin (ropivacaine hydrochloride) solution, 50
milligrams (mg)/10 milliliters (mL) and 75mg/10mL, were not withdrawn
from sale for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to withdraw approval of
abbreviated new drug applications (ANDAs) that refer to these drug
products, and it will allow FDA to continue to approve ANDAs that refer
to these drug products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Alexander Poonai, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3600, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
Naropin (ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/
10mL, are the subject of NDA 020533, held by Fresenius Kabi USA LLC,
and initially approved on May 1, 1998. Naropin is indicated for the
production of local or regional anesthesia for surgery and for acute
pain management.
Naropin (ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/
10mL, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated December 15, 2021 (Docket No. FDA-2021-P-1323), under 21 CFR
10.30, requesting that the Agency determine whether Naropin
(ropivacaine hydrochloride) solution, 50mg/10mL and 75mg/10mL, were
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that Naropin (ropivacaine hydrochloride) solution,
50mg/10mL and 75mg/10mL, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of Naropin (ropivacaine
hydrochloride) solution, 50mg/10mL and 75mg/10mL, from sale. We have
also independently
[[Page 71872]]
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that these drug products were not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list Naropin (ropivacaine
hydrochloride) solution, 50mg/10mL and 75mg/10mL, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to Naropin (ropivacaine hydrochloride)
solution, 50mg/10mL and 75mg/10mL, may be approved by the Agency as
long as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22960 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P
