Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 3467-3468 [2019-02032]
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3467
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS (CBER) 1—Continued
Number of
recordkeepers
21 CFR section
§ 312.62(a); Investigator recordkeeping of the disposition
of drugs ............................................................................
§ 312.62(b); Investigator recordkeeping of case histories of
individuals .........................................................................
§ 312.160(a)(3); Records pertaining to the shipment of
drugs for investigational use in laboratory research animals or in vitro tests .........................................................
§ 312.160(c); Shipper records of alternative disposition of
unused drugs ....................................................................
Total ..............................................................................
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
453
1
453
40
18,120
453
1
453
40
18,120
111
1.40
155
* 0.5
78
111
1.40
155
* 0.5
78
........................
........................
........................
........................
127,006
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Because we have received an
increased number of IND submissions
since the last OMB approval of the
information collection, we have
increased our estimate of the associated
burden accordingly.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
Hospira, Inc., et al.; Withdrawal of
Approval of 12 Abbreviated New Drug
Applications
[FR Doc. 2019–01962 Filed 2–11–19; 8:45 am]
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2019–N–0163]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 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applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
March 14, 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,
Trang.Tran@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.
DATES:
Application No.
Drug
Applicant
ANDA 065343 .............................
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake
Forest, IL 60045.
ANDA 070562 .............................
Epirubicin Hydrochloride (HCl) Injection USP, 10 milligrams (mg)/5 milliliters (mL), 50 mg/25 mL, 150
mg/75 mL, and 200 mg/100 mL.
Flurazepam HCl Capsules USP, 15 mg .....................
ANDA 070563 .............................
ANDA 071808 .............................
Flurazepam HCl Capsules USP, 30 mg .....................
Flurazepam HCl Capsules USP, 15 mg .....................
ANDA 071809 .............................
ANDA 076827 .............................
Flurazepam HCl Capsules USP, 30 mg .....................
Vinorelbine Injection USP, Equivalent to 10 mg base/
mL.
Polyethylene Glycol 3350 Powder for Oral Solution,
17 grams/scoopful.
ANDA 077736 .............................
ANDA 085763 .............................
Glutethimide Tablets, 500 mg .....................................
ANDA 085791 .............................
ANDA 087297 .............................
Pentobarbital Sodium Capsules, 100 mg ....................
Glutethimide Tablets, 500 mg .....................................
ANDA 088819 .............................
Aristocort A (triamcinolone acetonide) Cream, 0.1% ..
ANDA 089459 .............................
Glutethimide Tablets, 500 mg .....................................
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Pharmaceutical Basics, Inc., 301 South Cherokee
St., Denver, CO 80223.
Do.
Halsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY
11233.
Do.
Hospira, Inc.
Breckenridge Pharmaceutical, Inc., 6111 Broken
Sound Parkway NW, Suite 170, Boca Raton, FL
33487.
Chelsea Laboratories, Inc., 896 Orlando Ave., West
Hampstead, NY 11552.
Do.
Phoenix Pharmaceuticals, Inc., 111 Leuning St.,
South Hackensack, NJ 07606.
Astellas Pharma U.S., Inc., Three Parkway North,
Deerfield, IL 60015.
Halsey Drug Co., Inc.
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3468
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
Therefore, approval of the
applications listed in the table and all
amendments and supplements thereto,
are hereby withdrawn as of March 14,
2019. 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 March 14, 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: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02032 Filed 2–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Contact
Substance Notification Program
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: Fax written comments on the
collection of information by March 14,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0495. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
SUMMARY:
VerDate Sep<11>2014
18:30 Feb 11, 2019
Jkt 247001
North Bethesda, MD 20852, 301–796–
3794, 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:
Food Contact Substance Notification
Program—21 CFR 170.101, 170.106,
and 171.1
OMB Control Number 0910–0495—
Extension
This information collection supports
FDA regulations regarding Food Contact
Substance Notification, as well as
associated guidance and accompanying
forms. Section 409(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(h)) establishes a
premarket notification process for food
contact substances. Section 409(h)(6) of
the FD&C Act defines a ‘‘food contact
substance’’ as ‘‘any substance intended
for use as a component of materials used
in manufacturing, packing, packaging,
transporting, or holding food if such use
is not intended to have any technical
effect in such food.’’ Section 409(h)(3) of
the FD&C Act requires that the
notification process be used for
authorizing the marketing of food
contact substances except when: (1) We
determine that the submission and
premarket review of a food additive
petition (FAP) under section 409(b) of
the FD&C Act is necessary to provide
adequate assurance of safety or (2) we
and the manufacturer or supplier agree
that an FAP should be submitted.
Section 409(h)(1) of the FD&C Act
requires that a notification include: (1)
Information on the identity and the
intended use of the food contact
substance and (2) the basis for the
manufacturer’s or supplier’s
determination that the food contact
substance is safe under the intended
conditions of use.
Sections 170.101 and 170.106 of
FDA’s regulations (21 CFR 170.101 and
170.106) specify the information that a
notification must contain and require
that: (1) A food contact substance
notification (FCN) includes Form FDA
3480 and (2) a notification for a food
contact substance formulation includes
Form FDA 3479. These forms serve to
summarize pertinent information in the
notification. The forms facilitate both
preparation and review of notifications
because the forms will serve to organize
information necessary to support the
safety of the use of the food contact
substance. The burden of filling out the
appropriate form has been included in
the burden estimate for the notification.
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Currently, interested persons transmit
an FCN submission to the Office of Food
Additive Safety in the Center for Food
Safety and Applied Nutrition using
Form FDA 3480 whether it is submitted
in electronic or paper format. We
estimate that the amount of time for
respondents to complete Form FDA
3480 will continue to be the same.
In addition to its required use with
FCNs, Form FDA 3480 is recommended
to be used to organize information
within a Pre-notification Consultation or
Master File submitted in support of an
FCN according to the items listed on the
form. Master Files can be used as
repositories for information that can be
referenced in multiple submissions to
FDA, thus minimizing paperwork
burden for food contact substance
authorizations. We estimate that the
amount of time for respondents to
complete the Form FDA 3480 for these
types of submissions is 0.5 hours.
FDA recommends using Form FDA
3480A for each submission of additional
information (i.e., amendment) to an FCN
submission currently under Agency
review. Form FDA 3480A helps the
respondent organize the submission to
focus on the information needed for
FDA’s safety review.
FDA’s guidance documents entitled:
(1) ‘‘Preparation of Food Contact
Notifications: Administrative,’’ (2)
‘‘Preparation of Food Contact
Notifications and Food Additive
Petitions for Food Contact Substances:
Chemistry Recommendations,’’ and (3)
‘‘Preparation of Food Contact
Notifications for Food Contact
Substances: Toxicology
Recommendations’’ provide assistance
to industry regarding the preparation of
an FCN and a petition for a food contact
substances (FCSs). FDA has also
developed a draft guidance entitled,
‘‘Preparation of Food Contact
Notifications for Food Contact
Substances in Contact with Infant
Formula and/or Human Milk.’’ Once
finalized, the guidance will provide our
current thinking on how to prepare an
FCN for FDA review and evaluation of
the safety of FCSs used in contact with
infant formula and/or human milk.
These guidances are available at https://
www.fda.gov/Food/
GuidanceRegulation/
GuidanceDocuments
RegulatoryInformation/
IngredientsAdditivesGRASPackaging/
default.htm.
Section 171.1 of FDA’s regulations (21
CFR 171.1) specifies the information
that a petitioner must submit in order
to: (1) Establish that the proposed use of
an indirect food additive is safe and (2)
secure the publication of an indirect
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3467-3468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0163]
Hospira, Inc., et al.; Withdrawal of Approval of 12 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 12 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 March 14, 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,
Trang.Tran@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 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 065343................. Epirubicin Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection USP, 10 Bldg. H1, Lake
milligrams (mg)/5 Forest, IL 60045.
milliliters (mL),
50 mg/25 mL, 150 mg/
75 mL, and 200 mg/
100 mL.
ANDA 070562................. Flurazepam HCl Pharmaceutical
Capsules USP, 15 mg. Basics, Inc., 301
South Cherokee St.,
Denver, CO 80223.
ANDA 070563................. Flurazepam HCl Do.
Capsules USP, 30 mg.
ANDA 071808................. Flurazepam HCl Halsey Drug Co.,
Capsules USP, 15 mg. Inc., 1827 Pacific
St., Brooklyn, NY
11233.
ANDA 071809................. Flurazepam HCl Do.
Capsules USP, 30 mg.
ANDA 076827................. Vinorelbine Hospira, Inc.
Injection USP,
Equivalent to 10 mg
base/mL.
ANDA 077736................. Polyethylene Glycol Breckenridge
3350 Powder for Pharmaceutical,
Oral Solution, 17 Inc., 6111 Broken
grams/scoopful. Sound Parkway NW,
Suite 170, Boca
Raton, FL 33487.
ANDA 085763................. Glutethimide Chelsea
Tablets, 500 mg. Laboratories, Inc.,
896 Orlando Ave.,
West Hampstead, NY
11552.
ANDA 085791................. Pentobarbital Sodium Do.
Capsules, 100 mg.
ANDA 087297................. Glutethimide Phoenix
Tablets, 500 mg. Pharmaceuticals,
Inc., 111 Leuning
St., South
Hackensack, NJ
07606.
ANDA 088819................. Aristocort A Astellas Pharma
(triamcinolone U.S., Inc., Three
acetonide) Cream, Parkway North,
0.1%. Deerfield, IL
60015.
ANDA 089459................. Glutethimide Halsey Drug Co.,
Tablets, 500 mg. Inc.
------------------------------------------------------------------------
[[Page 3468]]
Therefore, approval of the applications listed in the table and all
amendments and supplements thereto, are hereby withdrawn as of March
14, 2019. 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 March 14, 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: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02032 Filed 2-11-19; 8:45 am]
BILLING CODE 4164-01-P
