
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9230-9235]
From the Federal Register Online via the Government Printing 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%)
                                    ====================================================================================================================
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).
                                    ====================================================================================================================
        Total......................  119 (15%)................................................  42 (25%)
                                    ====================================================================================================================
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%)
                                    ====================================================================================================================
        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).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  110......................................................  19
                                    ====================================================================================================================
Concluded PMCs:
    Commitment met (fulfilled).....  66 (58%).................................................  34 (85%)
    Commitment not met (released     0 (0)....................................................  0 (0)
     and new revised requirement/
     commitment issued).
                                    --------------------------------------------------------------------------------------------------------------------
    Commitment no longer feasible    47 (42%).................................................  6 (15%)
     or product withdrawn
     (released).
                                    --------------------------------------------------------------------------------------------------------------------
        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


