Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications, 65821-65822 [2019-25901]
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
65821
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section 2
Number of
recordkeepers
Number of
records per
recordkeeper 3
50
15,000
1
4
50
60,000
15,000
1
15,000
4,100
80
328,000
15,000
280
4,200,000
6,000
4
15,000
123.6(a)–(c); Prepare hazard analysis and HACCP plan
123.6(c)(5); Undertake and prepare records of corrective
actions.
123.8(a)(1) and (c); Reassess hazard analysis and
HACCP plan.
123.12(a)(2)(ii); Verify compliance of imports and prepare records of verification activities.
123.6(c)(7); Document monitoring of critical control
points.
123.7(d); Undertake and prepare records of corrective
actions due to a deviation from a critical limit.
123.8(d); Maintain records of the calibration of processmonitoring instruments and the performing of any periodic end-product and in-process testing.
123.11(c); Maintain sanitation control records .................
123.12(c); Maintain records that verify that the fish and
fishery products they offer for import into the United
States were processed in accordance with the
HACCP and sanitation provisions set forth in part 123.
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports.
Total ...........................................................................
Average burden
per recordkeeping 4
Total annual
records
Total hours
16 .....................
0.30 (18 minutes).
4 .......................
800
18,000
65,600
1,260,000
24,000
0.20 (12 minutes).
0.30 (18 minutes).
0.10 (6 minutes)
47
705,000
0.10 (6 minutes)
70,500
15,000
4,100
280
80
4,200,000
328,000
0.10 (6 minutes)
0.10 (6 minutes)
420,000
32,800
41
1
41
4 .......................
164
........................
........................
........................
...........................
1,930,264
60,000
2,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates include the information collection requirements in the following sections:
§ 123.16—Smoked Fish—process controls (see § 123.6(b));
§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b));
§ 123.28(c) and (d)—Records—molluscan shellfish (see § 123.6(c)(7).
3 Based on an estimated 280 working days per year.
4 Estimated average time per 8-hour work day unless one-time response.
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2 These
Based on a review of the information
collection since our last OMB approval,
we have made no adjustments to our
burden estimate. We base this hour
burden estimate on our experience with
the application of HACCP principles in
food processing. Further, the burdens
have been estimated using typical small
seafood processing firms as a model
because these firms represent a
significant proportion of the industry.
The hour burden of HACCP
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the size of the facility and
complexity of the HACCP control
scheme (i.e., the number of products
and the number of hazards controlled);
the daily frequency that control points
are monitored and values recorded; and
also on the extent that data recording
time and cost are minimized by the use
of automated data logging technology.
The burden estimate does not include
burden hours for activities that are a
usual and customary part of businesses’
normal activities. For example, the
tagging and labeling of molluscan
shellfish (§ 1240.60) is a customary and
usual practice among seafood
processors.
Dated: November 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25857 Filed 11–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0163]
Hospira, Inc., et al.; Withdrawal of
Approval of Six Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of six abbreviated
new drug applications (ANDAs) from
SUMMARY:
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
December 30, 2019.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 040806 .............................
Mepivacaine Hydrochloride (HCl) Injection USP, 3%,
30 milligrams (mg)/milliliter (mL).
Hospira, Inc., 275 North Field Dr., Bldg. H, Lake Forest, IL 60045.
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65822
Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
Application No.
Drug
Applicant
ANDA 077523 .............................
Fluconazole for Oral Suspension, 50 mg/5 mL and
200 mg/5 mL.
ANDA 078772 .............................
Epinephrine and Lidocaine HCl, 0.01 mg/mL; 2% and
0.02 mg/mL; 2%.
Articaine HCl and Epinephrine Bitartrate Injection,
4%; EQ 0.017 mg base/1.7 mL, 4%; EQ 0.01 mg
base/mL.
Norethindrone Acetate Tablets, 5 mg .........................
IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
Hospira, Inc.
ANDA 079138 .............................
ANDA 204236 .............................
ANDA 204421 .............................
Tramadol HCl Extended-Release Tablets, 100 mg,
200 mg, and 300 mg.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 30,
2019. Approval of each entire
application is withdrawn, including any
strengths or products inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on December 30, 2019
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25901 Filed 11–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5255]
Clinical Immunogenicity
Considerations for Biosimilar and
Interchangeable Insulin Products;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Clinical
Immunogenicity Considerations for
Biosimilar and Interchangeable Insulin
Products.’’ The purpose of this draft
guidance is to provide
recommendations to applicants
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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Do.
Aurobindo Pharma Ltd., 279 Princeton-Hightstown
Rd., East Windsor, NJ 08520.
Do.
regarding whether and when
comparative clinical immunogenicity
studies may be needed to support
licensure of proposed biosimilar and
interchangeable recombinant human
insulins, recombinant human insulin
mix products, and recombinant insulin
analog products that are intended for
the treatment of patients with Type 1 or
Type 2 diabetes mellitus.
Submit either electronic or
written comments on the draft guidance
by January 28, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–5255 for ‘‘Clinical
Immunogenicity Considerations for
Biosimilar and Interchangeable Insulin
Products.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
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]]>Agencies
[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65821-65822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0163]
Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 30, 2019.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040806................. Mepivacaine Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection USP, 3%, Bldg. H, Lake
30 milligrams (mg)/ Forest, IL 60045.
milliliter (mL).
[[Page 65822]]
ANDA 077523................. Fluconazole for Oral IVAX
Suspension, 50 mg/5 Pharmaceuticals,
mL and 200 mg/5 mL. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 078772................. Epinephrine and Hospira, Inc.
Lidocaine HCl, 0.01
mg/mL; 2% and 0.02
mg/mL; 2%.
ANDA 079138................. Articaine HCl and Do.
Epinephrine
Bitartrate
Injection, 4%; EQ
0.017 mg base/1.7
mL, 4%; EQ 0.01 mg
base/mL.
ANDA 204236................. Norethindrone Aurobindo Pharma
Acetate Tablets, 5 Ltd., 279 Princeton-
mg. Hightstown Rd.,
East Windsor, NJ
08520.
ANDA 204421................. Tramadol HCl Do.
Extended-Release
Tablets, 100 mg,
200 mg, and 300 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 30, 2019. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on December 30, 2019 may continue to be dispensed
until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever
occurs first.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25901 Filed 11-27-19; 8:45 am]
BILLING CODE 4164-01-P
