Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability, 9230-9235 [2014-03353]
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2014–N–0001]
2014 Medical Countermeasures
Initiative Regulatory Science
Symposium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: February 11, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–03358 Filed 2–14–14; 8:45 am]
Notice of meeting.
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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.
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:
SUMMARY:
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
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Sfmt 4703
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
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
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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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
§ 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 § 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
§§ 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
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initiative are not required to be reported
under §§ 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 § 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
approval2 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:
• 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.
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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9231
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
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 § 314.81(b)(2)(vii) or
§ 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
Additional information about PMRs/
PMCs is provided on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/
default.htm. Neither the Web site nor
this notice include information about
PMCs concerning chemistry,
manufacturing, and controls. It is FDA
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.
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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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. Onschedule PMRs/PMCs are categorized as
pending, ongoing, or submitted. Offschedule 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 onschedule 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 offschedule PMRs. The majority of offschedule 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 onschedule 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 offschedule PMCs. The majority of offschedule 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).
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.
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.
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.
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
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.
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III. About This Report
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
9233
TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS
[Numbers as of September 30, 2012]
Number of NDA/ANDA PMRs/PMCs
(% of total PMR or % of total PMC)
Number of open PMRs .....................................................
On-schedule open PMRs (see table 2 of this document).
Off-schedule open PMRs (see table 3 of this document).
Number of open PMCs ..............................................
On-schedule open PMCs (see table 4 of this document).
Off-schedule open PMCs (see table 5 of this document).
Number of BLA PMRs/PMCs
(% of total PMR or % of total PMC) 1
776 ............................................................
632 (81%) .................................................
167
139 (83%)
144 (19%) .................................................
28 (17%)
293 ............................................................
215 (73%) .................................................
263
200 (76%)
78 (27%) ...................................................
63 (24%)
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]
On-Schedule Open PMRs
Number of NDA/ANDA PMRs
(% of total PMR)
Number of BLA PMRs
(% of total PMR) 1
Pending (by type):
Accelerated approval .................................................
PREA 2 .......................................................................
Animal efficacy 3 ........................................................
FDAAA safety (since March 25, 2008) ......................
10 ..............................................................
236 ............................................................
2 ................................................................
203 ............................................................
2
24
0
50
Total ....................................................................
451 (58%) .................................................
76 (46%)
Ongoing:
Accelerated approval .................................................
PREA 2 .......................................................................
Animal efficacy 3 ........................................................
11 ..............................................................
40 ..............................................................
0 ................................................................
8
6
0
FDAAA safety (since March 25, 2008) ......................
68 ..............................................................
28
Total ....................................................................
119 (15%) .................................................
42 (25%)
Submitted:
Accelerated approval .................................................
PREA 2 .......................................................................
Animal efficacy 3 ........................................................
FDAAA safety (since March 25, 2008) ......................
0 ................................................................
20 ..............................................................
0 ................................................................
42 ..............................................................
1
7
0
13
Total ....................................................................
62 (8%) .....................................................
21 (13%)
Combined total ...................................................
632 (81%) .................................................
139 (84%)
1 See note 1 for table
2 Many PREA studies
1 of this document.
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 (§ 314.600 for drugs; § 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)
Delayed:
Accelerated approval .................................................
PREA .........................................................................
Animal efficacy ..........................................................
FDAAA safety (since March 25, 2008) ......................
5 ................................................................
107 ............................................................
1 ................................................................
28 ..............................................................
2
14
0
10
Total ....................................................................
141 (18.2%) ..............................................
26 (16%)
Terminated .........................................................
3 (0.4%) ....................................................
2 (1%)
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Number of BLA PMRs
(% of total PMR) 1
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TABLE 3—SUMMARY OF OFF-SCHEDULE POSTMARKETING REQUIREMENTS—Continued
[Numbers as of September 30, 2012]
Number of NDA/ANDA PMRs
(% of total PMR)
Off-schedule open PMRs
Combined total ...................................................
1 See
144 (19%) .................................................
Number of BLA PMRs
(% of total PMR) 1
28 (17%)
note 1 for table 1 of this document.
TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2012]
On-schedule open PMCs
Number of NDA/ANDA PMCs
(% of total PMC)
Pending .............................................................................
Ongoing ............................................................................
Submitted ..........................................................................
111 (38%) .................................................
56 (19%) ...................................................
48 (16%) ...................................................
79 (30%)
71 (27%)
50 (19%)
Combined total ..........................................................
215 (73%) .................................................
200 (76%)
1 See
Number of BLA PMCs
(% of total PMC) 1
note 1 for table 1 of this document.
TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2012]
Off-schedule open PMCs
Number of NDA/ANDA PMCs
(% of total PMC)
Delayed .............................................................................
Terminated ........................................................................
72 (25%) ...................................................
6 (2%) .......................................................
61 (23%)
2 (0.8%)
Combined tota ...........................................................
78 (27%) ...................................................
63 (24%)
1 See
Number of BLA PMCs
(% of total PMC) 1
note 1 for table 1 of this document.
TABLE 6—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS
[October 1, 2011 to October 1, 2012]
Number of NDA/ANDA PMRs/PMCs
(% of Total)
Concluded PMRs:
Requirement met (fulfilled) ........................................
Requirement not met (released and new revised requirement issued).
Requirement no longer feasible or product withdrawn (released).
Number of BLA PMRs/PMCs
(% of Total) 1
74 (67%) ...................................................
6 (6%) .......................................................
12 (63%)
1 (5%)
30 (27%) ...................................................
6 (32%)
Total ....................................................................
110 ............................................................
19
Concluded PMCs:
Commitment met (fulfilled) .........................................
Commitment not met (released and new revised requirement/commitment issued).
66 (58%) ...................................................
0 (0) ..........................................................
34 (85%)
0 (0)
Commitment no longer feasible or product withdrawn (released).
47 (42%) ...................................................
6 (15%)
Total ....................................................................
113 ............................................................
40
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1 See
note 1 for table 1 of this document.
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9235
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
SUMMARY:
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Care Services Outreach
Supplement Performance Measures.
OMB No. 0915–xxxx—NEW
Abstract: The fiscal year (FY) 2013
supplemental funding to the Rural
Health Care Services Outreach Program
grantees is a one-time supplemental
funding under Section 330A(e) of the
Public Health Service (PHS) Act (42
U.S.C. 254c(e)) to promote rural health
care services outreach by expanding the
delivery of health care services to
include new and enhanced services in
rural areas. The supplemental funding
will specifically focus on supporting the
current scope of their project, allowing
grantees to further enhance outreach
and enrollment assistance activities in
their communities. This supplemental
funding will support the Affordable
Care Act’s (ACA) outreach and
enrollment activities to the Health
Insurance Marketplaces. Grantees will
be able to raise awareness of affordable
insurance options and provide
assistance and information to the
uninsured about enrolling in available
sources of insurance, such as Medicare,
Medicaid, the Children’s Health
Insurance Program (CHIP), and private
insurance in the Marketplace through
this supplemental funding.
The overarching goal is to increase the
number of eligible individuals educated
about their coverage options and
Number of
responses per
respondent
Number of
respondents
Form name
enrollees to the Health Insurance
Marketplaces or other available sources
of insurance, such as Medicare,
Medicaid, and the Children’s Health
Insurance Program as a result of this
supplemental funding.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data. These measures cover the
principal topic areas of interest to the
Office of Rural Health Policy, including:
(a) Organizational information; (b)
outreach and enrollment personnel; (c)
outreach and education; (d) enrollment;
and (e) additional resources. Several
measures will be used for this program.
Likely Respondents: The respondents
would be recipients of the Rural Health
Care Services Outreach supplemental
funding award.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total responses
Average burden
per response
(in hours)
Total burden
hours
52
1
52
1.5
78
Total ................................................
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Rural Health Care Services Outreach
Supplement Performance Measures ..
52
1
52
1.5
78
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
VerDate Mar<15>2010
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technology to minimize the information
collection burden.
Dated: February 10, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–03442 Filed 2–14–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
BILLING CODE 4165–15–P
PO 00000
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\2\ Some applicants have requested and been granted by FDA
alternate annual reporting dates to facilitate harmonized reporting
across multiple applications.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
Additional information about PMRs/PMCs is provided on FDA's Web
site at https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
[[Page 9233]]
Table 1--Summary of Postmarketing Requirements and Commitments
[Numbers as of September 30, 2012]
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
On-Schedule Open PMRs Number of NDA/ANDA PMRs (% of total PMR) Number of BLA PMRs (% of total PMR) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pending (by type):
Accelerated approval........... 10....................................................... 2
PREA \2\....................... 236...................................................... 24
Animal efficacy \3\............ 2........................................................ 0
FDAAA safety (since March 25, 203...................................................... 50
2008).
--------------------------------------------------------------------------------------------------------------------
Total...................... 451 (58%)................................................ 76 (46%)
====================================================================================================================
Ongoing:
Accelerated approval........... 11....................................................... 8
PREA \2\....................... 40....................................................... 6
Animal efficacy \3\............ 0........................................................ 0
--------------------------------------------------------------------------------------------------------------------
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).
--------------------------------------------------------------------------------------------------------------------
Total...................... 62 (8%).................................................. 21 (13%)
====================================================================================================================
Combined total............. 632 (81%)................................................ 139 (84%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Off-schedule open PMRs Number of NDA/ANDA PMRs (% of total PMR) Number of BLA PMRs (% of total PMR) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Delayed:
Accelerated approval........... 5........................................................ 2
PREA........................... 107...................................................... 14
Animal efficacy................ 1........................................................ 0
FDAAA safety (since March 25, 28....................................................... 10
2008).
--------------------------------------------------------------------------------------------------------------------
Total...................... 141 (18.2%).............................................. 26 (16%)
--------------------------------------------------------------------------------------------------------------------
Terminated................. 3 (0.4%)................................................. 2 (1%)
====================================================================================================================
[[Page 9234]]
Combined total............. 144 (19%)................................................ 28 (17%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
Table 4--Summary of On-Schedule Postmarketing Commitments
[Numbers as of September 30, 2012]
--------------------------------------------------------------------------------------------------------------------------------------------------------
On-schedule open PMCs Number of NDA/ANDA PMCs (% of total PMC) Number of BLA PMCs (% of total PMC) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pending............................ 111 (38%)................................................ 79 (30%)
Ongoing............................ 56 (19%)................................................. 71 (27%)
Submitted.......................... 48 (16%)................................................. 50 (19%)
--------------------------------------------------------------------------------------------------------------------
Combined total................. 215 (73%)................................................ 200 (76%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
Table 5--Summary of Off-Schedule Postmarketing Commitments
[Numbers as of September 30, 2012]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Off-schedule open PMCs Number of NDA/ANDA PMCs (% of total PMC) Number of BLA PMCs (% of total PMC) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Delayed............................ 72 (25%)................................................. 61 (23%)
Terminated......................... 6 (2%)................................................... 2 (0.8%)
--------------------------------------------------------------------------------------------------------------------
Combined tota.................. 78 (27%)................................................. 63 (24%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of NDA/ANDA PMRs/PMCs (% of Total) Number of BLA PMRs/PMCs (% of Total) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
