Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction, 59144 [2011-24400]

Download as PDF sroberts on DSK5SPTVN1PROD with NOTICES 59144 Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Notices meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 23, 2011. 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[FR Doc. 2011–24532 Filed 9–22–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0318] Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 21, 2010 (75 FR 42455). The document withdrew approval of 27 new drug applications (NDAs) and 58 abbreviated new drug applications (ANDAs) from multiple applicants. The published document excluded a footnote in the table. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, Silver Spring, MD 20993–0002, 301– 796–9148. In FR Doc. 2010–17785, appearing on page 42455, in the Federal Register of Wednesday, July 21, 2010, the following correction is made: 1. On page 42456, in Table 1, under the ‘‘Drug’’ column, correct the entry for ‘‘Proventil (albuterol USP) Inhalation Aerosol’’ to read ‘‘Proventil (albuterol USP) Inhalation Aerosol 1’’. 2. On page 42456, at the end of the table, add footnote number 1 to read: SUPPLEMENTARY INFORMATION: This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any albuterol metered-dose inhalers. (See 70 FR 17168, April 4, 2005.) Dated: September 19, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–24400 Filed 9–22–11; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Practitioner Data Bank; Name Change of Proactive Disclosure Service (PDS) to Continuous Query AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: On March 7, 2007, the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), published in the Federal Register a notice announcing the implementation of a prototype for querying the National Practitioner Data Bank (NPDB), then known as Proactive Disclosure Service (PDS). This notice announces that the prototype status is removed and that PDS is now known as Continuous Query. DATES: The effective date of this status upgrade and name change is September 23, 2011. FOR FURTHER INFORMATION CONTACT: Director, Division of Practitioner Data Banks, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, 5600 Fishers Lane, Room 8–103, Rockville, MD 20857; telephone number: (301) 443–2300. SUPPLEMENTARY INFORMATION: I. Background On March 7, 2007, the National Practitioner Data Bank (NPDB) published in the Federal Register (72 FR 10227) a notice announcing a Proactive Disclosure Service (PDS) prototype. The PDS was offered as an alternative to the traditional querying of the NPDB and allowed for on-going monitoring of a practitioner’s credentials. PDS is a subscription service that notifies subscribers, which are registered entities that are eligible to query the NPDB or the Healthcare Integrity and Protection Data Bank (HIPDB), of new information on any of their enrolled practitioners within 24 hours of the NPDB or HIPDB receipt of the information. The PDS prototype was available for enrollment beginning on April 30, 2007 to a select group of NPDB registered entities. A few months later PDS was opened to all NPDB registered entities, as well as to those registered in the HIPDB. In the last year (July 1, 2010 through June 30, 2011), 1,965 entities had practitioner enrollments through PDS versus 14,370 entities that submitted traditional queries on E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Page 59144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]


Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 
27 New Drug Applications and 58 Abbreviated New Drug Applications; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of July 21, 2010 (75 FR 42455). 
The document withdrew approval of 27 new drug applications (NDAs) and 
58 abbreviated new drug applications (ANDAs) from multiple applicants. 
The published document excluded a footnote in the table. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, 
Silver Spring, MD 20993-0002, 301-796-9148.

SUPPLEMENTARY INFORMATION: In FR Doc. 2010-17785, appearing on page 
42455, in the Federal Register of Wednesday, July 21, 2010, the 
following correction is made:
    1. On page 42456, in Table 1, under the ``Drug'' column, correct 
the entry for ``Proventil (albuterol USP) Inhalation Aerosol'' to read 
``Proventil (albuterol USP) Inhalation Aerosol \1\''.
    2. On page 42456, at the end of the table, add footnote number 1 to 
read:

    This product included an oral pressurized metered-dose inhaler 
that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may 
no longer be used as a propellant for any albuterol metered-dose 
inhalers. (See 70 FR 17168, April 4, 2005.)


    Dated: September 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24400 Filed 9-22-11; 8:45 am]
BILLING CODE 4160-01-P

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