[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52669-52670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21487]
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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.
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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]
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NDA/ANDA (% of BLA (% of Total
Total PMR or % of PMR or % of total
total PMC) PMC) \1\
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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).
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\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]
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