Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications, 23795-23796 [2019-10809]
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23795
Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices
The Office of Planning,
Research, and Evaluation and the
Family and Youth Services Bureau
(FYSB) in the Administration for
Children and Families propose data
collection activities as part of the Sexual
Risk Avoidance Education (SRAE)
Program Performance Analysis Study
(PAS). The goal of the study is to
collect, analyze, and report on
performance measures data for SRAE
programs.
SUMMARY:
Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
DATES:
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
ADDRESSES:
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Description: The purpose of the SRAE
program is to educate youth on ‘‘how to
voluntarily refrain from non-marital
sexual activity and prevent other youth
risk behaviors.’’ Data will be used to
determine if the SRAE grantees are
meeting performance benchmarks
related to their program’s mission and
priorities.
Respondents: Departmental (DSRAE),
State (SSRAE), and Competitive
(CSRAE) grantees, their subawardees,
and program participants.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondents
Average
burden hours
per response
Annual
burden
hours
(1) Participant Entry Survey
DSRAE participants .............................................................
SSRAE participants .............................................................
CSRAE participants .............................................................
161,916
1,108,456
29,108
53,972
369,485
9,703
1
1
1
0.1333
0.1333
0.1333
7,195
49,252
1,293
1
1
1
0.2667
0.2667
0.2667
11,552
78,834
2,033
2
2
2
16
16
16
1,600
1,248
1,536
2
2
2
13
13
13
29,900
23,400
7,202
(2) Participant Exit Survey
DSRAE participants .............................................................
SSRAE participants .............................................................
CSRAE participants .............................................................
129,948
886,768
22,871
43,316
295,589
7,624
(3) Performance Reporting Data Entry Form—Grantees
DSRAE grantees ..................................................................
SSRAE grantees ..................................................................
CSRAE grantees ..................................................................
150
117
144
50
39
48
(4) Performance Reporting Data Entry Form—Sub Awardees
DSRAE subawardees ..........................................................
SSRAE subawardees ..........................................................
CSRAE subawardees ..........................................................
Estimated Total Annual Burden
Hours: 215,045.
Authority: 42 U.S.C. 1310.
3,450
2,700
831
1,150
900
277
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Mary B. Jones,
ACF/OPRE Certifying Officer.
BILLING CODE 4184–83–P
Bedford Laboratories, et al.;
Withdrawal of Approval of 24
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
khammond on DSKBBV9HB2PROD with NOTICES
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 24 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
16:40 May 22, 2019
Jkt 247001
PO 00000
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Fmt 4703
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY:
VerDate Sep<11>2014
Approval is withdrawn as of
June 24, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2019–N–1524]
[FR Doc. 2019–10762 Filed 5–22–19; 8:45 am]
and requested that the approval of the
applications be withdrawn.
Sfmt 4703
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23MYN1
23796
Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
Application No.
Drug
Applicant
ANDA 040524 ......................
ANDA 070857 ......................
Promethazine Hydrochloride (HCl) Injection USP, 25
milligrams (mg)/milliliter (mL) and 50 mg/mL.
Trazodone HCl Tablets USP, 50 mg ..............................
ANDA 070987 ......................
Diazepam Tablets USP, 2 mg ........................................
ANDA 070996 ......................
ANDA 071717 ......................
Diazepam Tablets USP, 5 mg ........................................
Flurazepam HCl Capsules USP, 15 mg and 30 mg ......
ANDA 071751 ......................
ANDA 071752 ......................
ANDA 077190 ......................
Methyldopa Tablets USP, 125 mg ..................................
Methyldopa Tablets USP, 250 mg ..................................
Milrinone Lactate Injection, EQ 1 mg base/mL ..............
ANDA 077703 ......................
Pamidronate Disodium for Injection USP, 30 mg/vial
and 90 mg/vial.
ANDA
ANDA
ANDA
ANDA
ANDA 083930 ......................
ANDA 084676 ......................
ANDA 085088 ......................
Prednisone Tablets USP, 5 mg ......................................
Chlorpheniramine Maleate Tablets USP, 4 mg ..............
Niacin Tablets USP, 500 mg ..........................................
Kloromin (chlorpheniramine maleate) Tablets USP, 4
mg.
Dextroamphetamine Sulfate Tablets USP, 10 mg ..........
Secobarbital Sodium Capsules USP, 100 mg ................
Hydralazine HCl Tablets USP, 50 mg ............................
Bedford Laboratories, 300 Northfield Rd., Bedford, OH
44146.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Halsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY
11233.
Do.
Aurolife Pharma, LLC, 279 Princeton Hightstown Rd.,
East Windsor, NJ 08520.
Halsey Drug Co., Inc.
Do.
Gland Pharma, Ltd., c/o INC Research, LLC, 4800
Falls of Neuse Rd., Suite 600, Raleigh, NC 27609.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ
08512.
Halsey Drug Co., Inc.
Aurolife Pharma, LLC.
Halsey Drug Co., Inc.
Do.
ANDA 085219 ......................
ANDA 085923 ......................
ANDA 087279 ......................
Hydrochlorothiazide Tablets, 50 mg ...............................
Amitriptyline HCl Tablets USP, 10 mg ............................
Butalbital, Aspirin, and Caffeine Tablets .........................
ANDA 088116 ......................
Myfed (pseudoephedrine HCl and triprolidine HCl)
Syrup, 30 mg/5 mL and 1.25 mg/5 mL.
Chlorpropamide Tablets USP, 100 mg ...........................
Hydralazine HCl Tablets USP, 25 mg ............................
Hydralazine HCl Tablets USP, 100 mg ..........................
Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg .....
ANDA
ANDA
ANDA
ANDA
khammond on DSKBBV9HB2PROD with NOTICES
§ 314.150(c) is without prejudice to
refiling.
080300
080961
083453
083629
088725
089130
089178
201484
......................
......................
......................
......................
......................
......................
......................
......................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 24, 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 June 24, 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: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10809 Filed 5–22–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:40 May 22, 2019
Jkt 247001
Do.
Do.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr.,
Maple Grove, MN 55369.
Aurolife Pharma, LLC.
Halsey Drug Co., Inc.
Sandoz, Inc., 227–15 North Conduit Ave., Laurelton,
NY 11413.
USL Pharma, LLC, 301 South Cherokee St., Denver,
CO 80223.
Aurolife Pharma, LLC.
Halsey Drug Co., Inc.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Maternal and Child
Health Bureau Performance Measures
for Discretionary Grant Information
System (DGIS), OMB No. 0915–0298—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
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of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
Comments on this ICR should be
received no later than June 24, 2019.
DATES:
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
ADDRESSES:
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
1984.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal and Child Health Bureau
Performance Measures for Discretionary
Grant Information System (DGIS), OMB
No. 0915–0298—Revision.
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 84, Number 100 (Thursday, May 23, 2019)]
[Notices]
[Pages 23795-23796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1524]
Bedford Laboratories, et al.; Withdrawal of Approval of 24
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 24 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 June 24, 2019.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[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
[[Page 23796]]
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 040524................. Promethazine Bedford
Hydrochloride (HCl) Laboratories, 300
Injection USP, 25 Northfield Rd.,
milligrams (mg)/ Bedford, OH 44146.
milliliter (mL) and
50 mg/mL.
ANDA 070857................. Trazodone HCl Watson Laboratories,
Tablets USP, 50 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 070987................. Diazepam Tablets Halsey Drug Co.,
USP, 2 mg. Inc., 1827 Pacific
St., Brooklyn, NY
11233.
ANDA 070996................. Diazepam Tablets Do.
USP, 5 mg.
ANDA 071717................. Flurazepam HCl Aurolife Pharma,
Capsules USP, 15 mg LLC, 279 Princeton
and 30 mg. Hightstown Rd.,
East Windsor, NJ
08520.
ANDA 071751................. Methyldopa Tablets Halsey Drug Co.,
USP, 125 mg. Inc.
ANDA 071752................. Methyldopa Tablets Do.
USP, 250 mg.
ANDA 077190................. Milrinone Lactate Gland Pharma, Ltd.,
Injection, EQ 1 mg c/o INC Research,
base/mL. LLC, 4800 Falls of
Neuse Rd., Suite
600, Raleigh, NC
27609.
ANDA 077703................. Pamidronate Disodium Sun Pharma Global
for Injection USP, FZE, c/o Sun
30 mg/vial and 90 Pharmaceutical
mg/vial. Industries, Inc.,
270 Prospect Plains
Rd., Cranbury, NJ
08512.
ANDA 080300................. Prednisone Tablets Halsey Drug Co.,
USP, 5 mg. Inc.
ANDA 080961................. Chlorpheniramine Aurolife Pharma,
Maleate Tablets LLC.
USP, 4 mg.
ANDA 083453................. Niacin Tablets USP, Halsey Drug Co.,
500 mg. Inc.
ANDA 083629................. Kloromin Do.
(chlorpheniramine
maleate) Tablets
USP, 4 mg.
ANDA 083930................. Dextroamphetamine Do.
Sulfate Tablets
USP, 10 mg.
ANDA 084676................. Secobarbital Sodium Do.
Capsules USP, 100
mg.
ANDA 085088................. Hydralazine HCl Upsher-Smith
Tablets USP, 50 mg. Laboratories, LLC,
6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 085219................. Hydrochlorothiazide Aurolife Pharma,
Tablets, 50 mg. LLC.
ANDA 085923................. Amitriptyline HCl Halsey Drug Co.,
Tablets USP, 10 mg. Inc.
ANDA 087279................. Butalbital, Aspirin, Sandoz, Inc., 227-15
and Caffeine North Conduit Ave.,
Tablets. Laurelton, NY
11413.
ANDA 088116................. Myfed USL Pharma, LLC, 301
(pseudoephedrine South Cherokee St.,
HCl and Denver, CO 80223.
triprolidine HCl)
Syrup, 30 mg/5 mL
and 1.25 mg/5 mL.
ANDA 088725................. Chlorpropamide Aurolife Pharma,
Tablets USP, 100 mg. LLC.
ANDA 089130................. Hydralazine HCl Halsey Drug Co.,
Tablets USP, 25 mg. Inc.
ANDA 089178................. Hydralazine HCl Do.
Tablets USP, 100 mg.
ANDA 201484................. Levofloxacin Watson Laboratories,
Tablets, 250 mg, Inc., Subsidiary of
500 mg, and 750 mg. Teva
Pharmaceuticals
USA, Inc.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
24, 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 June 24, 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: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10809 Filed 5-22-19; 8:45 am]
BILLING CODE 4164-01-P
