[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9230-9235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03353]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0006]
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: Under the Food and Drug Administration Modernization Act of
1997 (FDAMA), the Food and Drug Administration (FDA) 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. This 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.
FOR FURTHER INFORMATION CONTACT: Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Food and Drug Administration Modernization Act
Section 130(a) of FDAMA (Pub. L. 105-115) amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by adding a new provision
requiring reports of certain postmarketing studies, including clinical
trials, for human drug and biological products (section 506B of the
FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act provides FDA
with additional authority to monitor the progress of a postmarketing
study or clinical trial that an applicant has been required to, or has
agreed to, conduct by requiring the applicant to submit a report
annually providing information on the status of the postmarketing
study/clinical trial. This report must also include reasons, if any,
for failure to complete the study/clinical trial. These studies and
clinical trials are intended to further define the safety, efficacy, or
optimal use of a product, and therefore play a vital role in fully
characterizing the product.
Under FDAMA, commitments to conduct postmarketing studies or
clinical trials included both studies/clinical trials that applicants
agreed to conduct, as well as studies/clinical trials that applicants
were required to conduct under FDA regulations.\1\
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\1\ Before passage of FDAAA, FDA could require postmarketing
studies and clinical trials under the following circumstances: To
verify and describe clinical benefit for a human drug approved in
accordance with the accelerated approval provisions in section
506(b)(2)(A) of the FD&C Act (21 CFR 314.510 and 601.41); for a drug
approved on the basis of animal efficacy data because human efficacy
trials are not ethical or feasible (21 CFR 314.610(b)(1) and
601.91(b)(1)); and for marketed drugs that are not adequately
labeled for children under section 505B of the FD&C Act (Pediatric
Research Equity Act; Pub. L. 108-155).
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B. The Food and Drug Administration Amendments Act of 2007
On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the FD&C Act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
FD&C Act or section 351 of the Public Health Service Act (42 U.S.C.
262). Under FDAAA, FDA has been given additional authority to require
applicants to conduct and report on postmarketing studies and clinical
trials to assess a known serious risk, assess signals of serious risk,
or identify an unexpected serious risk related to the use of a product.
This new authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f)(4) of the FD&C Act (21 U.S.C. 355(o)(1), 352(z), and
333(f)(4))).
Although regulations implementing FDAMA postmarketing authorities
use
[[Page 9231]]
the term ``postmarketing commitment'' to refer to both required studies
and studies applicants agree to conduct, in light of the new
authorities enacted in FDAAA, FDA has decided it is important to
distinguish between enforceable postmarketing requirements and
unenforceable postmarketing commitments. Therefore, in this notice and
report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.
C. FDA's Implementing Regulations
On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of FDAMA. This rule modified the annual report
requirements for new drug applications (NDAs) and abbreviated new drug
applications (ANDAs) by revising Sec. 314.81(b)(2)(vii) (21 CFR
314.81(b)(2)(vii)). The rule also created a new annual reporting
requirement for biologics license applications (BLAs) by establishing
Sec. 601.70 (21 CFR 601.70). The rule described the content and format
of the annual progress report, and clarified the scope of the reporting
requirement and the timing for submission of the annual progress
reports. The regulations became effective on April 30, 2001 (66 FR
10815). The regulations apply only to human drug and biological
products approved under NDAs, ANDAs, and BLAs. They do not apply to
animal drugs or to biological products regulated under the medical
device authorities.
The reporting requirements under Sec. Sec. 314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of FDAMA
(November 21, 1997), as well as those made after that date. Therefore,
studies and clinical trials required under FDAAA are covered by the
reporting requirements in these regulations.
Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial either
required by FDA or that they have committed to conduct, either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec. 314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(3)(E) of the FD&C Act,
as amended by FDAAA, requires that applicants report periodically on
the status of each required study/clinical trial and each study/
clinical trial ``otherwise undertaken * * * to investigate a safety
issue * * *.''
According to the regulations, once a PMR has been required, or a
PMC has been agreed upon, an applicant must report on the progress of
the PMR/PMC on the anniversary of the product's approval\2\ until the
PMR/PMC is completed or terminated and FDA determines that the PMR/PMC
has been fulfilled or that the PMR/PMC is either no longer feasible or
would no longer provide useful information. The annual progress report
must include a description of the PMR/PMC, a schedule for completing
the PMR/PMC, and a characterization of the current status of the PMR/
PMC. The report must also provide an explanation of the PMR/PMC status
by describing briefly the progress of the PMR/PMC. A PMR/PMC schedule
is expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of the
study/clinical trial, and (3) submission of the final report to FDA.
The status of the PMR/PMC must be described in the annual report
according to the following definitions:
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\2\ Some applicants have requested and been granted by FDA
alternate annual reporting dates to facilitate harmonized reporting
across multiple applications.
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Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or initiation of animal dosing has not
passed);
Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
Delayed: The study/clinical trial is behind the original
schedule;
Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).
II. Summary of Information From Postmarketing Status Reports
This report, published to fulfill the annual reporting requirement
under FDAMA, summarizes the status of PMRs and PMCs as of September 30,
2012. If a requirement or commitment did not have a schedule, or a
postmarketing progress report was not received in the previous 12
months, the PMR/PMC is categorized according to the most recent
information available to the Agency.\3\
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\3\ Although the data included in this report do not include a
summary of reports that applicants have failed to file by their due
date, the Agency notes that it may take appropriate regulatory
action in the event reports are not filed on a timely basis.
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Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o) (3) of the FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to demonstrate clinical benefit of a
product following accelerated approval (see footnote 1 of this
document)), and PMCs agreed to by the applicant.
Information summarized in this report includes the following: (1)
The number of applicants with open PMRs/PMCs, (2) the number of open
PMRs/PMCs, (3) FDA-verified status of open PMRs/PMCs reported in Sec.
314.81(b)(2)(vii) or Sec. 601.70 annual reports, (4) the status of
concluded PMRs/PMCs as determined by FDA, and (5) the number of
applications for which an annual report was expected, but was not
submitted within 60 days of the anniversary date of U.S. approval or an
alternate reporting date that has been granted by FDA.\4\
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\4\ The type of information included in this report is the same
as in previous ones. However, as a result of improved data capture
and refinement of analytical methods, some values in the fiscal year
(FY) 2012 report are notably different from those reported in the
previous reports. FDA intends to use the data capture and analytical
methods applied to the FY2012 report in future annual reports. For
clarity and comparison purposes, relevant data for the FY2012 report
are provided using both the updated and previously used methods (see
footnotes 5, 7, and 8).
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Additional information about PMRs/PMCs is provided on FDA's Web
site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm. Neither the Web site nor this
notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA
[[Page 9232]]
policy not to post information on the Web site until it has been
verified and reviewed for suitability for public disclosure. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the status information reported in
this notice will be updated annually while the Web site is updated
quarterly (i.e., in January, April, July, and October).
An applicant may have multiple approved products, and an approved
product may have multiple PMRs and/or PMCs. As of September 30, 2012,
there were 172 unique applicants with 1,069 open PMRs/PMCs under 476
unique NDAs/ANDAs.\5\ For BLAs, there were 72 unique applicants with
430 open PMRs/PMCs under 101 unique applications.
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\5\ The number of unique NDAs/ANDAs (476) is noticeably
different from the corresponding number in the FY2011 Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments (77 FR 13339, March 6, 2012). The
FY2011 calculation (198) was based on PMRs/PMCs that were both open
at the end of the FY and had received a status update during the
year. The FY2012 calculation includes all PMRs/PMCs open at the end
of FY2012, regardless of when the last status update occurred.
Applying FY2011 calculation methods to FY2012 results in 252 unique
NDAs/ANDAs with open PMRs/PMCs.
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Applicants must submit an annual status report on the progress of
each open PMR/PMC within 60 days of the anniversary date of U.S.
approval of the original application or an alternate reporting date
that has been granted by FDA. There were 432 NDAs/ANDAs with an annual
status report due in fiscal year (FY) 2012.\6\ Of the 432 annual status
reports due, 61 percent (264/432) were received on time; \7\ 19 percent
(82/432) were received, but not on time; and 20 percent (86/432) were
not received at any time during FY2012.\8\
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\6\ The number of expected annual status reports (432) is
different from the total number of unique NDAs/ANDAs with open PMRs/
PMCs (476) because not all NDAs/ANDAs had an annual status report
due during FY2012. PMRs/PMCs associated with multiple NDAs/ANDAs may
submit the annual status report to only one of the applications. In
addition, if all of the PMRs/PMCs for an application were
established in FY2012, or if all PMRs/PMCs for an application were
concluded before the annual status report due date, submission of an
annual status report would not be expected.
\7\ In the FY2011 FR notice, the percentage of NDA/ANDA annual
status reports submitted on time (79 percent) was based on
applications that had both an open PMR/PMC as of September 30, 2011,
and had received an annual report during the FY. The corresponding
FY2012 calculation is based on applications with an annual status
report due date during FY2012, regardless of whether a report was
actually received during the FY or whether PMRs/PMCs were closed as
of September 30, 2012. Applying the FY2011 calculation method to
FY2012 results in 84 percent (166/197) of NDA/ANDA annual status
reports submitted on time.
\8\ The FY2011 FR notice reported that 100 percent of the annual
status reports due, but not submitted on time, were submitted before
the close of FY2011. The corresponding percentage is only 49 percent
in FY2012. In FY2011, the percentage of annual reports not received
on time was based only on reports received within FY2011. The FY2012
calculation considers all reports expected, not just those actually
received during FY2012. Applying the FY2011 calculation method to
FY2012 results in 100 percent (31/31) of annual status reports due,
but not submitted on time, that were submitted before the close of
FY2012.
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For BLAs, there were 101 annual status reports expected in FY2012.
Of those expected, 68 percent (69/101) were received on time; 12
percent (12/101) were received, but not on time; and 20 percent (20/
101) were not received at any time during FY2012.
III. About This Report
This report provides six separate summary tables. The tables in
this document distinguish between PMRs and PMCs and between on-schedule
and off-schedule PMRs and PMCs according to the original schedule
milestones. On-schedule PMRs/PMCs are categorized as pending, ongoing,
or submitted. Off-schedule PMRs/PMCs that have missed one of the
original milestone dates are categorized as delayed or terminated. The
tables include data as of September 30, 2012.
Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 of this document provides additional detail on the status
of on-schedule PMRs.
Table 1 of this document shows that most open PMRs (81 percent for
NDAs/ANDAs and 83 percent for BLAs) and most open PMCs (73 percent for
NDAs/ANDAs and 76 percent for BLAs) are progressing on schedule (i.e.,
are not delayed or terminated). Overall, of the PMRs that are pending
(i.e., have not been initiated, but do not meet the definition for
delayed), 78 percent (411/527) were created within the past 3 years.
Table 2 of this document shows that 53 percent (260/527) of pending
PMRs for drug and biological products are in response to the Pediatric
Research and Equity Act (PREA), under which FDA requires sponsors to
study new drugs, when appropriate, for pediatric populations. Under
section 505B(a)(3) (21 U.S.C. 355c(a)(3)) of the FD&C Act, the
initiation of these studies generally is deferred until required safety
information from other studies has first been submitted and reviewed.
PMRs for products approved under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for biological products) can be
conducted only when the product is used for its indication as a
counterterrorism measure. In the absence of a public health emergency,
these studies/clinical trials will remain pending indefinitely. The
next largest category of pending PMRs for drug and biological products
(45 percent, 253/527) comprises those studies/clinical trials required
by FDA under FDAAA, which became effective on March 25, 2008.
Table 3 of this document provides additional detail on the status
of off-schedule PMRs. The majority of off-schedule PMRs (which account
for 19 percent of the total for NDAs/ANDAs and 17 percent for BLAs) are
delayed according to the original schedule milestones (98 percent (141/
144) for NDAs/ANDAs; 93 percent (26/28) for BLAs). In certain
situations, the original schedules may have been adjusted for
unanticipated delays in the progress of the study/clinical trial (e.g.,
difficulties with subject enrollment in a trial for a marketed drug or
need for additional time to analyze results). In this report, study/
clinical trial status reflects the status in relation to the original
study/clinical trial schedule regardless of whether FDA has
acknowledged that additional time may be required to complete the
study/;clinical trial.
Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 of this document provides additional detail on
the status of on-schedule PMCs. Pending PMCs comprise 52 percent (111/
215) of the on-schedule NDA/ANDA PMCs and 40 percent (79/200) of the
on-schedule BLA PMCs.
Table 5 of this document provides additional details on the status
of off-schedule PMCs. The majority of off-schedule PMCs (which account
for 27 percent for NDAs/ANDAs and 24 percent for BLAs) are delayed
according to the original schedule milestones (92 percent (72/78) for
NDAs/ANDAs; 97 percent (61/63) for BLAs).
Table 6 of this document provides details about PMRs and PMCs that
were concluded in FY2012. The majority of concluded PMRs and PMCs were
fulfilled (67 percent of NDA/ANDA PMRs and 63 percent of BLA PMRs; 58
percent of NDA/ANDA PMCs and 85 percent of BLA PMCs).
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Table 1--Summary of Postmarketing Requirements and Commitments
[Numbers as of September 30, 2012]
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Number of NDA/ANDA PMRs/PMCs (% of total PMR or % of Number of BLA PMRs/PMCs (% of total PMR or % of total
total PMC) PMC) \1\
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Number of open PMRs................ 776...................................................... 167
On-schedule open PMRs (see 632 (81%)................................................ 139 (83%)
table 2 of this document).
Off-schedule open PMRs (see 144 (19%)................................................ 28 (17%)
table 3 of this document).
Number of open PMCs............ 293...................................................... 263
On-schedule open PMCs (see 215 (73%)................................................ 200 (76%)
table 4 of this document).
Off-schedule open PMCs (see 78 (27%)................................................. 63 (24%)
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.
Table 2--Summary of On-Schedule Postmarketing Requirements
[Numbers as of September 30, 2012]
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On-Schedule Open PMRs Number of NDA/ANDA PMRs (% of total PMR) Number of BLA PMRs (% of total PMR) \1\
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Pending (by type):
Accelerated approval........... 10....................................................... 2
PREA \2\....................... 236...................................................... 24
Animal efficacy \3\............ 2........................................................ 0
FDAAA safety (since March 25, 203...................................................... 50
2008).
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Total...................... 451 (58%)................................................ 76 (46%)
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Ongoing:
Accelerated approval........... 11....................................................... 8
PREA \2\....................... 40....................................................... 6
Animal efficacy \3\............ 0........................................................ 0
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FDAAA safety (since March 25, 68....................................................... 28
2008).
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Total...................... 119 (15%)................................................ 42 (25%)
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Submitted:
Accelerated approval........... 0........................................................ 1
PREA \2\....................... 20....................................................... 7
Animal efficacy \3\............ 0........................................................ 0
FDAAA safety (since March 25, 42....................................................... 13
2008).
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Total...................... 62 (8%).................................................. 21 (13%)
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Combined total............. 632 (81%)................................................ 139 (84%)
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\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually deferred because the product is ready for approval in adults. Initiation of these
studies may be deferred until additional safety information from other studies has first been submitted and reviewed.
\3\ PMRs for products approved under the animal efficacy rule (Sec. 314.600 for drugs; Sec. 601.90 for biological products) can be conducted only
when the product is used for its indication as a counterterrorism measure. In the absence of a public health emergency, these studies/clinical trials
will remain pending indefinitely.
Table 3--Summary of Off-Schedule Postmarketing Requirements
[Numbers as of September 30, 2012]
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Off-schedule open PMRs Number of NDA/ANDA PMRs (% of total PMR) Number of BLA PMRs (% of total PMR) \1\
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Delayed:
Accelerated approval........... 5........................................................ 2
PREA........................... 107...................................................... 14
Animal efficacy................ 1........................................................ 0
FDAAA safety (since March 25, 28....................................................... 10
2008).
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Total...................... 141 (18.2%).............................................. 26 (16%)
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Terminated................. 3 (0.4%)................................................. 2 (1%)
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Combined total............. 144 (19%)................................................ 28 (17%)
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\1\ See note 1 for table 1 of this document.
Table 4--Summary of On-Schedule Postmarketing Commitments
[Numbers as of September 30, 2012]
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On-schedule open PMCs Number of NDA/ANDA PMCs (% of total PMC) Number of BLA PMCs (% of total PMC) \1\
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Pending............................ 111 (38%)................................................ 79 (30%)
Ongoing............................ 56 (19%)................................................. 71 (27%)
Submitted.......................... 48 (16%)................................................. 50 (19%)
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Combined total................. 215 (73%)................................................ 200 (76%)
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\1\ See note 1 for table 1 of this document.
Table 5--Summary of Off-Schedule Postmarketing Commitments
[Numbers as of September 30, 2012]
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Off-schedule open PMCs Number of NDA/ANDA PMCs (% of total PMC) Number of BLA PMCs (% of total PMC) \1\
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Delayed............................ 72 (25%)................................................. 61 (23%)
Terminated......................... 6 (2%)................................................... 2 (0.8%)
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Combined tota.................. 78 (27%)................................................. 63 (24%)
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\1\ See note 1 for table 1 of this document.
Table 6--Summary of Concluded Postmarketing Requirements and Commitments
[October 1, 2011 to October 1, 2012]
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Number of NDA/ANDA PMRs/PMCs (% of Total) Number of BLA PMRs/PMCs (% of Total) \1\
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Concluded PMRs:
Requirement met (fulfilled).... 74 (67%)................................................. 12 (63%)
Requirement not met (released 6 (6%)................................................... 1 (5%)
and new revised requirement
issued).
Requirement no longer feasible 30 (27%)................................................. 6 (32%)
or product withdrawn
(released).
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Total...................... 110...................................................... 19
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Concluded PMCs:
Commitment met (fulfilled)..... 66 (58%)................................................. 34 (85%)
Commitment not met (released 0 (0).................................................... 0 (0)
and new revised requirement/
commitment issued).
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Commitment no longer feasible 47 (42%)................................................. 6 (15%)
or product withdrawn
(released).
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Total...................... 113...................................................... 40
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\1\ See note 1 for table 1 of this document.
[[Page 9235]]
Dated: February 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03353 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P