83_FR_6230 83 FR 6200 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction

83 FR 6200 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 30 (February 13, 2018)

Page Range6200-6200
FR Document2018-02926

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document erroneously included abbreviated new drug application (ANDA) 075726 for Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error.

Federal Register, Volume 83 Issue 30 (Tuesday, February 13, 2018) 
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6200]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0002]


Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug 
Applications and 158 Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of October 4, 2016 (81 FR 68427). 
The document announced the withdrawal of approval of 44 new drug 
applications and 158 abbreviated new drug applications (ANDAs) from 
multiple applicants, effective November 3, 2016. The document 
erroneously included abbreviated new drug application (ANDA) 075726 for 
Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by 
Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October 
4, 2016, appearing on page 68427 in FR Doc. 2016-23893, the following 
correction is made:
    1. On page 68430, in table 1, the entry for ANDA 075726 is removed.
    In a separate notice published in this issue of the Federal 
Register, FDA is withdrawing the approval of ANDA 075726 under 21 CFR 
314.150(d).

    Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02926 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P

6200 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices ADDRESSES: All statements of interest II. Selection Procedure U.S.C. app. 2) and 21 CFR part 14, from industry organizations interested relating to advisory committees. in participating in the selection process Any industry organization interested in participating in the selection of an Dated: February 7, 2018. of nonvoting industry representative nomination should be sent to Margaret appropriate nonvoting member to Leslie Kux, Ames (see FOR FURTHER INFORMATION represent industry interests should send Associate Commissioner for Policy. CONTACT). All nominations for a a letter stating that interest to the FDA [FR Doc. 2018–02922 Filed 2–12–18; 8:45 am] nonvoting industry representative contact (see FOR FURTHER INFORMATION BILLING CODE 4164–01–P should be submitted electronically by CONTACT) within 30 days of publication accessing the FDA Advisory Committee of this document (see DATES). Within the Membership Nomination Portal: https:// subsequent 30 days, FDA will send a DEPARTMENT OF HEALTH AND www.accessdata.fda.gov/scripts/ letter to each organization that has HUMAN SERVICES FACTRSPortal/FACTRS/index.cfm or by expressed an interest, attaching a mail to Advisory Committee Oversight complete list of all such organizations; Food and Drug Administration and Management Staff, Food and Drug and a list of all nominees along with Administration, 10903 New Hampshire their current résumés. The letter will [Docket No. FDA–2016–N–0002] Ave., Bldg. 32, Rm. 5103, Silver Spring, also state that it is the responsibility of MD 20993–0002. Information about the interested organizations to confer Hospira, Inc. et al.; Withdrawal of becoming a member of an FDA advisory with one another and to select a Approval of 44 New Drug Applications committee can also be obtained by candidate, within 60 days after the and 158 Abbreviated New Drug visiting FDA’s website at https:// receipt of the FDA letter, to serve as the Applications; Correction www.fda.gov/AdvisoryCommittees/ nonvoting member to represent industry default.htm. interests for the committee. The AGENCY: Food and Drug Administration, interested organizations are not bound HHS. FOR FURTHER INFORMATION CONTACT: by the list of nominees in selecting a Margaret Ames, Division of Workforce candidate. However, if no individual is ACTION: Notice; correction. Management, Center for Devices and selected within 60 days, the Radiological Health, Food and Drug Commissioner will select the nonvoting SUMMARY: The Food and Drug Administration, 10903 New Hampshire member to represent industry interests. Administration (FDA) is correcting a Ave., Bldg. 66, Rm. 5264, Silver Spring, notice that appeared in the Federal MD 20993, 301–796–5960, Fax: 301– III. Nomination Procedure Register of October 4, 2016 (81 FR 847–8505, email: margaret.ames@ Individuals may self-nominate and/or 68427). The document announced the fda.hhs.gov. an organization may nominate one or withdrawal of approval of 44 new drug more individuals to serve as a nonvoting applications and 158 abbreviated new SUPPLEMENTARY INFORMATION: The drug applications (ANDAs) from Agency is requesting nominations for a industry representative. Nominations must include a current, complete multiple applicants, effective November nonvoting industry representative on 3, 2016. The document erroneously the National Mammography Quality résumé or curriculum vitae for each nominee and a signed copy of the included abbreviated new drug Assurance Advisory Committee: application (ANDA) 075726 for Acknowledgement and Consent form I. General Description of the Committee available at the FDA Advisory Pemoline Tablets, 18.75 milligrams Duties Nomination Portal (see ADDRESSES). (mg), 37.5 mg, and 75 mg, held by Nominations must also specify the Mallinkrodt Pharmaceuticals, LLC. This The Committee shall advise FDA on: notice corrects that error. (1) Developing appropriate quality advisory committee for which the standards and regulations for nominee is recommended. Nominations FOR FURTHER INFORMATION CONTACT: mammography facilities; (2) developing must also acknowledge that the Florine Purdie, Center for Drug appropriate standards and regulations nominee is aware of the nomination Evaluation and Research, Food and for bodies accrediting mammography unless self-nominated. FDA will Drug Administration, 10903 New facilities under this program; (3) forward all nominations to the Hampshire Ave., Bldg. 51, Rm. 6248, developing regulations with respect to organizations expressing interest in Silver Spring, MD 20993–0002, 301– sanctions; (4) developing procedures for participating in the selection process for 796–3601. monitoring compliance with standards; the committee. (Persons who nominate themselves as nonvoting industry SUPPLEMENTARY INFORMATION: In the (5) establishing a mechanism to Federal Register of Tuesday, October 4, investigate consumer complaints; (6) representatives will not participate in the selection process.) 2016, appearing on page 68427 in FR reporting new developments concerning Doc. 2016–23893, the following breast imaging that should be FDA seeks to include the views of women and men, members of all racial correction is made: considered in the oversight of mammography facilities; (7) and ethnic groups, and individuals with 1. On page 68430, in table 1, the entry determining whether there exists a and without disabilities on its advisory for ANDA 075726 is removed. shortage of mammography facilities in committees and therefore encourages In a separate notice published in this rural and health professional shortage nominations of appropriately qualified issue of the Federal Register, FDA is areas and determining the effects of candidates from these groups. withdrawing the approval of ANDA sradovich on DSK3GMQ082PROD with NOTICES personnel on access to the services of Specifically, in this document, 075726 under 21 CFR 314.150(d). such facilities in these areas; (8) nominations for a nonvoting Dated: February 8, 2018. determining whether there will exist a representative of industry interests are encouraged from the mammography Leslie Kux, sufficient number of medical physicists after October 1, 1999; and (9) manufacturing industry. Associate Commissioner for Policy. determining the costs and benefits of This notice is issued under the [FR Doc. 2018–02926 Filed 2–12–18; 8:45 am] compliance with these requirements. Federal Advisory Committee Act (5 BILLING CODE 4164–01–P VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 E:\FR\FM\13FEN1.SGM 13FEN1


Document Created: 2018-02-13 02:32:24
Document Modified: 2018-02-13 02:32:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; correction.
ContactFlorine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation83 FR 6200 
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