Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction, 6200 [2018-02926]

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

Agencies

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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