2011-21487. 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 Total PMR or % of total PMC)	BLA (% of Total PMR or % of total PMC) 1
Number of open PMRs	526	149.
On-schedule open PMRs (see table 2 of this document)	477 (91%)	131 (88%).
Off-schedule open PMRs (see table 3 of this document)	49 (9%)	18 (12%).
Number of open PMCs 2	473	307.
On-schedule open PMCs (see table 4 of this document)	399 (84%)	236 (77%).
Off-schedule open PMCs (see table 5 of this document)	74 (16%)	71 (23%).
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.

Dated: August 17, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.