Document ID: FDA-2011-N-0332-0002
Agency: fda
Document Type: Notice
Title: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Correction
Posted Date: 2011-08-23T04:00Z

[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52669-52670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21487]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0332]

Report on the Performance of Drug and Biologics Firms in 
Conducting Postmarketing Requirements and Commitments; Availability; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
of availability that appeared in the Federal Register of August 4, 2011 
(76 FR 47211). The Agency is required to report annually in the Federal 
Register on the status of postmarketing requirements and commitments 
required of, or agreed upon by, holders of approved drug and biological 
products. The August 4, 2011, notice is the Agency's report on the 
status of the studies and clinical trials that applicants have agreed 
to, or are required to, conduct. The document was published with an 
error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and 
Planning, 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. 2011-19806, appearing on page 
47211 in the Federal Register of August 4, 2011, the following 
correction is made:
    On page 47214, table 1 is corrected to read as follows:

     Table 1--Summary of Postmarketing Requirements and Commitments
                   [Numbers as of September 30, 2010]
------------------------------------------------------------------------
                                    NDA/ANDA (% of      BLA (% of Total
                                  Total PMR or % of    PMR or % of total
                                      total PMC)           PMC) \1\
------------------------------------------------------------------------
Number of open PMRs............  526                  149.
    On-schedule open PMRs (see   477 (91%)            131 (88%).
     table 2 of this document).
    Off-schedule open PMRs (see  49 (9%)              18 (12%).
     table 3 of this document).
Number of open PMCs \2\........  473                  307.
    On-schedule open PMCs (see   399 (84%)            236 (77%).
     table 4 of this document).
    Off-schedule open PMCs (see  74 (16%)             71 (23%).
     table 5 of this document).
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  therapeutic products formerly regulated by CBER into CDER.
  Consequently, CDER now reviews many BLAs. Fiscal year statistics for
  postmarketing requirements and commitments for BLAs reviewed by CDER
  are included in BLA totals in this table.
\2\ The number of PMCs reported as open as of September 30, 2009, in the
  ``Report on the Performance of Drug and Biologics Firms in Conducting
  Postmarketing Requirements and Commitments'' notice published in the
  Federal Register on November 9, 2010 (75 FR 68802), inadvertently also
  included open PMRs. That error has been corrected for the current
  reporting period.

[[Page 52670]]

    Dated: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21487 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P