Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction, 19491 [2020-07265]
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Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made
adjustments to our burden estimate to
account for advances in information and
communication technology that have
occurred in the last decade. Because the
transition from paper-based to
electronic records systems is
widespread, we estimate that the
average burden per recordkeeping has
decreased by 50 percent. With regards to
records maintenance, we estimate that
approximately 379,493 facilities each
spend half the amount of time from the
13.228 hours previously reported to 6.61
hours collecting, recording, and
checking for accuracy of the limited
amount of additional information
required by the regulations, for a total of
2,508,449 hours annually. In addition,
we estimate that new firms entering the
affected businesses incur a burden from
learning the regulatory requirements
and understanding the records required
for compliance. In this regard, we
estimate the number of new firms
entering the affected businesses is 5
percent of 379,493, or 18,975 firms.
Thus, we estimate that approximately
18,975 facilities each spend, on average,
4.5 hours learning about the
recordkeeping and records access
requirements, for a total of 85,388 hours
annually. This estimate reflects a
reduction from 4.79 to 4.5 average hours
per facility to account for the increase
in facilities using internet, which
increased from 71 to 99 percent. We
estimate that approximately the same
number of firms (18,975) exit the group
of affected businesses in any given year,
resulting in no growth in the number of
total firms reported on line 1 of table 1.
and Drug Administration (FDA), like
other government agencies, is taking the
necessary steps to ensure the Agency is
prepared to continue our vital public
health mission in the event that our dayto-day operations are impacted by the
COVID–19 public health emergency.
Therefore, we are canceling or
postponing all non-essential meetings
through the month of April. We will
reassess on an ongoing basis for future
months. Therefore, this meeting is being
postponed. The meeting was announced
in the Federal Register on February 20,
2020.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
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area. Please call the Information Line for
up-to-date information on this meeting,
which was announced in the Federal
Register of February 20, 2020 (85 FR
9780).
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2019–N–5550]
[FR Doc. 2020–07275 Filed 4–6–20; 8:45 am]
BILLING CODE 4164–01–P
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07262 Filed 4–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
SUMMARY:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Pulmonary-Allergy Drugs Advisory
Committee (PADAC) scheduled for
April 21, 2020, is postponed. The Food
SUMMARY:
VerDate Sep<11>2014
18:22 Apr 06, 2020
Jkt 250001
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
AGENCY:
Pulmonary-Allergy Drugs Advisory
Committee; Postponed
York, NY 10016: ANDA 073191,
Triamterene and Hydrochlorothiazide
Capsules USP, 50 milligrams (mg)/25
mg; ANDA 076075, Econazole Nitrate
Cream, 1%; ANDA 076192, Ribavirin
Capsules USP, 200 mg; ANDA 076514,
Midodrine Hydrochloride (HCl) Tablets
USP, 2.5 mg, 5 mg, and 10 mg; ANDA
086809, Spironolactone Tablets USP, 25
mg; ANDA 090288, Naratriptan Tablets
USP, Equivalent to (EQ) 1 mg base and
EQ 2.5 mg base; and ANDA 203384,
Epinastine HCl Ophthalmic Solution,
0.05%. Before FDA withdrew the
approval of these ANDAs, CASI
Pharmaceuticals, Inc., informed FDA
that it did not want the approval of the
ANDAs withdrawn. Because CASI
Pharmaceuticals, Inc., timely requested
that approval of these ANDAs not be
withdrawn, the approval of ANDAs
073191, 076075, 076192, 076514,
086809, 090288, and 203384 is still in
effect.
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: In the
Federal Register of Wednesday, January
8, 2020 (85 FR 909), in FR Doc. 2020–
00076, on page 909, the following
correction is made:
1. On pages 909 and 910, in the table,
the entries for ANDAs 073191, 076075,
076192, 076514, 086809, 090288, and
203384 are removed.
[FR Doc. 2020–07265 Filed 4–6–20; 8:45 am]
Elite Laboratories, Inc., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications;
Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2020–N–0626]
19491
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on January 8, 2020. The
document announced the withdrawal of
approval of 23 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of February 7,
2020. The document indicated that FDA
was withdrawing approval of the
following seven ANDAs after receiving
a withdrawal request from CASI
Pharmaceuticals, Inc., c/o Target Health,
Inc., 261 Madison Ave., 24th Floor, New
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Ryan White HIV/AIDS Program Part F;
AIDS Education and Training Centers;
National HIV Curriculum e-Learning
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Health Resources and Services
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Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
HRSA’s HIV/AIDS Bureau
will award $100,000 in supplemental
funding to the University of Washington
to support the AIDS Education and
Training Centers’ (AETC) National HIV
SUMMARY:
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[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Page 19491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5550]
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23
Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on January 8, 2020. The document
announced the withdrawal of approval of 23 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of February
7, 2020. The document indicated that FDA was withdrawing approval of
the following seven ANDAs after receiving a withdrawal request from
CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave.,
24th Floor, New York, NY 10016: ANDA 073191, Triamterene and
Hydrochlorothiazide Capsules USP, 50 milligrams (mg)/25 mg; ANDA
076075, Econazole Nitrate Cream, 1%; ANDA 076192, Ribavirin Capsules
USP, 200 mg; ANDA 076514, Midodrine Hydrochloride (HCl) Tablets USP,
2.5 mg, 5 mg, and 10 mg; ANDA 086809, Spironolactone Tablets USP, 25
mg; ANDA 090288, Naratriptan Tablets USP, Equivalent to (EQ) 1 mg base
and EQ 2.5 mg base; and ANDA 203384, Epinastine HCl Ophthalmic
Solution, 0.05%. Before FDA withdrew the approval of these ANDAs, CASI
Pharmaceuticals, Inc., informed FDA that it did not want the approval
of the ANDAs withdrawn. Because CASI Pharmaceuticals, Inc., timely
requested that approval of these ANDAs not be withdrawn, the approval
of ANDAs 073191, 076075, 076192, 076514, 086809, 090288, and 203384 is
still in effect.
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: In the Federal Register of Wednesday,
January 8, 2020 (85 FR 909), in FR Doc. 2020-00076, on page 909, the
following correction is made:
1. On pages 909 and 910, in the table, the entries for ANDAs
073191, 076075, 076192, 076514, 086809, 090288, and 203384 are removed.
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07265 Filed 4-6-20; 8:45 am]
BILLING CODE 4164-01-P
