Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 3467-3468 [2019-02032]

Download as PDF 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Approval is withdrawn as of March 14, 2019.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 ..................................... VerDate Sep<11>2014 18:30 Feb 11, 2019 Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. E:\FR\FM\12FEN1.SGM 12FEN1 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. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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]


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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