Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability, 5069-5070 [E7-1749]
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Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Commitment Studies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA) is required, under
the Food and Drug Administration
Modernization Act of 1997
(Modernization Act), to report annually
in the Federal Register on the status of
postmarketing study commitments
made by sponsors of approved drug and
biological products. This is the agency’s
report on the status of the studies
sponsors have agreed to or are required
to conduct.
FOR FURTHER INFORMATION CONTACT:
Beth Duvall-Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993–0002,
301–796–0700;or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration,
1400 Rockville Pike, Rockville, MD
20852, 301–827–0373.
SUPPLEMENTARY INFORMATION:
sroberts on PROD1PC70 with NOTICES
I. Background
Section 130(a) of the Modernization
Act (Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
requiring reports of certain
postmarketing studies (section 506B of
the act (21 U.S.C. 356b)) for human drug
and biological products. Section 506B of
the act provides FDA with additional
authority to monitor the progress of a
postmarketing study commitment that
an applicant has been required or has
agreed to conduct by requiring the
applicant to submit a report annually
providing information on the status of
the postmarketing study commitment.
This report must also include reasons, if
any, for failure to complete the
commitment.
On December 1, 1999 (64 FR 67207),
FDA published a proposed rule
providing a framework for the content
and format of the annual progress
report. The proposed rule also clarified
the scope of the reporting requirement
and the timing for submission of the
annual progress reports. The final rule,
published on October 30, 2000 (65 FR
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
64607), modified 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).
These regulations became effective on
April 30, 2001. The regulations apply
only to human drug and biological
products. They do not apply to animal
drug or to biological products that also
meet the definition of a medical device.
Sections 314.81(b)(2)(vii) and 601.70
apply to postmarketing commitments
made on or before enactment of the
Modernization Act (November 21, 1997)
as well as those made after that date.
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 that is required by FDA
(e.g., accelerated approval clinical
benefit studies) 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
other types of postmarketing
commitments (e.g., those concerning
chemistry, manufacturing, production
controls, and studies conducted on an
applicant’s own 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).
According to the regulations, once a
postmarketing study commitment has
been made, an applicant must report on
the progress of the commitment on the
anniversary of the product’s approval
until the postmarketing study
commitment is completed or
terminated, and FDA determines that
the postmarketing study commitment
has been fulfilled or that the
postmarketing study commitment is
either no longer feasible or would no
longer provide useful information. The
annual progress report must include a
description of the postmarketing study
commitment, a schedule for completing
the study commitment, and a
characterization of the current status of
the study commitment. The report must
also provide an explanation of the
postmarketing study commitment’s
status by describing briefly the
postmarketing study commitment’s
progress. A postmarketing study
commitment schedule is expected to
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5069
include the actual or projected dates for
the following: (1) Submission of the
study protocol to FDA, (2) completion of
patient accrual or initiation of an animal
study, (3) completion of the study, and
(4) submission of the final study report
to FDA. The postmarketing study
commitment status must be described in
the annual report according to the
following definitions:
• Pending: The study has not been
initiated (i.e., no subjects have been
enrolled or animals dosed), but does not
meet the criterion for delayed (i.e., the
original projected date for initiation of
patient accrual or initiation of animal
dosing has not passed);
• Ongoing: The study is proceeding
according to or ahead of the original
schedule;
• Delayed: The study is behind the
original schedule;
• Terminated: The study was ended
before completion, but a final study
report has not been submitted to FDA;
or
• Submitted: The study has been
completed or terminated, and a final
study report has been submitted to FDA.
Databases containing information on
postmarketing study commitments are
maintained at the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER). Information in this
report covers any postmarketing study
commitment that was made, in writing,
at the time of approval or after approval
of an application or a supplement to an
application, including those required
(e.g., to demonstrate clinical benefit of
a product following accelerated
approval) and those agreed to with the
applicant. Information summarized in
this report includes: (1) The number of
applicants with open (uncompleted)
postmarketing commitments, (2) the
number of open postmarketing
commitments, (3) the status of open
postmarketing commitments as reported
in § 314.81(b)(2)(vii) or § 601.70 annual
reports, (4) the status of concluded
postmarketing studies as determined by
FDA, and (5) the number of applications
with open postmarketing commitments
for which sponsors did not submit an
annual report within 60 days of the
anniversary date of U.S. approval.
Additional information about
postmarketing study commitments
made by sponsors to CDER and CBER
are provided on FDA’s Web site at
https://www.fda.gov/cder. Like this
document, the site does not list
postmarketing study commitments
containing proprietary information. It is
FDA policy not to post information on
the Web site until it has been reviewed
for accuracy. The numbers published in
E:\FR\FM\02FEN1.SGM
02FEN1
5070
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices
this document cannot be compared with
the numbers resulting from searches of
the Web site. This document
incorporates totals for all postmarketing
study commitments in FDA databases,
including those undergoing review for
accuracy. The report in this document
will be updated annually while the Web
site is updated quarterly (in January,
April, July, and October).
II. Summary of Information From
Postmarketing Study Progress Reports
This report summarizes the status of
postmarketing commitments as of
September 30, 2006. If a commitment
did not have a schedule or a
postmarketing progress report was not
received, the commitment is categorized
according to the most recent
information available to the agency.
Data in table 1 of this document are
numerical summaries generated from
FDA databases. The data are broken out
according to application type (NDAs/
ANDAs or BLAs).
TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2006)
BLAs1 (% of Total)
NDAs/ANDAs (% of Total)
Applicants With Open Postmarketing
Commitments
127
45
1,259
373
899 (71%)
184 (15%)
31 (3%)
1 (<1%)
144 (11%)
127 (34%)
90 (24%)
78 (21%)
2 (1%)
76 (20%)
194
160 (83%)
10 (5%)
38
33 (87%)
0
24 (12%)
5 (13%)
133 (37%)2
33 (47%)
Number of Open Postmarketing Commitments
Status of Open Postmarketing Commitments
• Pending
• Ongoing
• Delayed
• Terminated
• Submitted
Concluded Studies (October 1, 2005
Through September 30, 2006)
• Commitment Met
• Commitment Not Met
• Study No Longer Needed or Feasible
Applications With Open Postmarketing
Commitments With Annual Reports
Due, But Not Submitted Within 60
Days of the Anniversary Date of
U.S. Approval
1 On
October 1, 2003, FDA completed a consolidation of certain products formerly regulated by the CBER into CDER. The previous association of BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year (FY) statistics for CDER
BLA postmarketing study commitments will continue to be counted under BLA totals in this table.
2 Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in FY 2006 for 133/133 (100%) of
NDAs/ANDAs and 15/33 (45%) of BLAs.
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Comissioner for Policy.
[FR Doc. E7–1749 Filed 2–1–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
sroberts on PROD1PC70 with NOTICES
Automated Commercial Environment
(ACE): National Customs Automation
Program Test of Automated Truck
Manifest for Truck Carrier Accounts;
Deployment Schedule
Customs and Border Protection;
Department of Homeland Security.
ACTION: General notice.
AGENCY:
SUMMARY: The Bureau of Customs and
Border Protection, in conjunction with
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
the Department of Transportation,
Federal Motor Carrier Safety
Administration, is currently conducting
a National Customs Automation
Program (NCAP) test concerning the
transmission of automated truck
manifest data. This document
announces a new group, or cluster, of
ports to be deployed for this test.
DATES: The ports identified in this
notice, all in the state of North Dakota,
are expected to be fully deployed for
testing by January 31, 2007. Comments
concerning this notice and all aspects of
the announced test may be submitted at
any time during the test period.
FOR FURTHER INFORMATION CONTACT: Mr.
James Swanson via e-mail at
james.d.swanson@dhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The National Customs Automation
Program (NCAP) test concerning the
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Frm 00073
Fmt 4703
Sfmt 4703
transmission of automated truck
manifest data for truck carrier accounts
was announced in a General Notice
published in the Federal Register (69
FR 55167) on September 13, 2004. That
notice stated that the test of the
Automated Truck Manifest would be
conducted in a phased approach, with
primary deployment scheduled for no
earlier than November 29, 2004.
A series of Federal Register notices
have announced the implementation of
the test, beginning with a notice
published on May 31, 2005 (70 FR
30964). As described in that document,
the deployment sites for the test have
been phased in as clusters. The ports
identified belonging to the first cluster
were announced in the May 31, 2005,
notice. Additional clusters were
announced in subsequent notices
published in the Federal Register
including: 70 FR 43892, published on
July 29, 2005; 70 FR 60096, published
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5069-5070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1749]
[[Page 5069]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Commitment Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is required, under the
Food and Drug Administration Modernization Act of 1997 (Modernization
Act), to report annually in the Federal Register on the status of
postmarketing study commitments made by sponsors of approved drug and
biological products. This is the agency's report on the status of the
studies sponsors have agreed to or are required to conduct.
FOR FURTHER INFORMATION CONTACT:
Beth Duvall-Miller, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993-0002, 301-796-0700;or
Robert Yetter, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD
20852, 301-827-0373.
SUPPLEMENTARY INFORMATION:
I. Background
Section 130(a) of the Modernization Act (Public Law 105-115)
amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a
new provision requiring reports of certain postmarketing studies
(section 506B of the act (21 U.S.C. 356b)) for human drug and
biological products. Section 506B of the act provides FDA with
additional authority to monitor the progress of a postmarketing study
commitment that an applicant has been required or has agreed to conduct
by requiring the applicant to submit a report annually providing
information on the status of the postmarketing study commitment. This
report must also include reasons, if any, for failure to complete the
commitment.
On December 1, 1999 (64 FR 67207), FDA published a proposed rule
providing a framework for the content and format of the annual progress
report. The proposed rule also clarified the scope of the reporting
requirement and the timing for submission of the annual progress
reports. The final rule, published on October 30, 2000 (65 FR 64607),
modified 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). These regulations
became effective on April 30, 2001. The regulations apply only to human
drug and biological products. They do not apply to animal drug or to
biological products that also meet the definition of a medical device.
Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing
commitments made on or before enactment of the Modernization Act
(November 21, 1997) as well as those made after that date. 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 that is required by FDA (e.g., accelerated
approval clinical benefit studies) 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 other types of postmarketing commitments
(e.g., those concerning chemistry, manufacturing, production controls,
and studies 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).
According to the regulations, once a postmarketing study commitment
has been made, an applicant must report on the progress of the
commitment on the anniversary of the product's approval until the
postmarketing study commitment is completed or terminated, and FDA
determines that the postmarketing study commitment has been fulfilled
or that the postmarketing study commitment is either no longer feasible
or would no longer provide useful information. The annual progress
report must include a description of the postmarketing study
commitment, a schedule for completing the study commitment, and a
characterization of the current status of the study commitment. The
report must also provide an explanation of the postmarketing study
commitment's status by describing briefly the postmarketing study
commitment's progress. A postmarketing study commitment schedule is
expected to include the actual or projected dates for the following:
(1) Submission of the study protocol to FDA, (2) completion of patient
accrual or initiation of an animal study, (3) completion of the study,
and (4) submission of the final study report to FDA. The postmarketing
study commitment status must be described in the annual report
according to the following definitions:
Pending: The study has not been initiated (i.e., no
subjects have been enrolled or animals dosed), but does not meet the
criterion for delayed (i.e., the original projected date for initiation
of patient accrual or initiation of animal dosing has not passed);
Ongoing: The study is proceeding according to or ahead of
the original schedule;
Delayed: The study is behind the original schedule;
Terminated: The study was ended before completion, but a
final study report has not been submitted to FDA; or
Submitted: The study has been completed or terminated, and
a final study report has been submitted to FDA.
Databases containing information on postmarketing study commitments
are maintained at the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER).
Information in this report covers any postmarketing study commitment
that was made, in writing, at the time of approval or after approval of
an application or a supplement to an application, including those
required (e.g., to demonstrate clinical benefit of a product following
accelerated approval) and those agreed to with the applicant.
Information summarized in this report includes: (1) The number of
applicants with open (uncompleted) postmarketing commitments, (2) the
number of open postmarketing commitments, (3) the status of open
postmarketing commitments as reported in Sec. 314.81(b)(2)(vii) or
Sec. 601.70 annual reports, (4) the status of concluded postmarketing
studies as determined by FDA, and (5) the number of applications with
open postmarketing commitments for which sponsors did not submit an
annual report within 60 days of the anniversary date of U.S. approval.
Additional information about postmarketing study commitments made
by sponsors to CDER and CBER are provided on FDA's Web site at https://www.fda.gov/cder. Like this document, the site does not list
postmarketing study commitments containing proprietary information. It
is FDA policy not to post information on the Web site until it has been
reviewed for accuracy. The numbers published in
[[Page 5070]]
this document cannot be compared with the numbers resulting from
searches of the Web site. This document incorporates totals for all
postmarketing study commitments in FDA databases, including those
undergoing review for accuracy. The report in this document will be
updated annually while the Web site is updated quarterly (in January,
April, July, and October).
II. Summary of Information From Postmarketing Study Progress Reports
This report summarizes the status of postmarketing commitments as
of September 30, 2006. If a commitment did not have a schedule or a
postmarketing progress report was not received, the commitment is
categorized according to the most recent information available to the
agency.
Data in table 1 of this document are numerical summaries generated
from FDA databases. The data are broken out according to application
type (NDAs/ANDAs or BLAs).
Table 1.--Summary of Postmarketing Study Commitments (Numbers as of September 30, 2006)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/ANDAs (% of Total) BLAs\1\ (% of Total)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applicants With Open Postmarketing Commitments 127 45
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Open Postmarketing Commitments 1,259 373
--------------------------------------------------------------------------------------------------------------------------------------------------------
Status of Open Postmarketing Commitments ............................................. .............................................
Pending 899 (71%) 127 (34%)
Ongoing 184 (15%) 90 (24%)
Delayed 31 (3%) 78 (21%)
Terminated 1 (<1%) 2 (1%)
Submitted 144 (11%) 76 (20%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Concluded Studies (October 1, 2005 Through September 30, 194 38
2006)
Commitment Met 160 (83%) 33 (87%)
Commitment Not Met 10 (5%) 0
Study No Longer Needed or Feasible 24 (12%) 5 (13%)
Applications With Open Postmarketing Commitments With 133 (37%)\2\ 33 (47%)
Annual Reports Due, But Not Submitted Within 60 Days of
the Anniversary Date of U.S. Approval
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain products formerly regulated by the CBER into CDER. The previous association of BLA
reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year (FY) statistics for CDER BLA postmarketing study
commitments will continue to be counted under BLA totals in this table.
\2\ Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including
reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as
having overdue annual reports using this definition, annual reports were subsequently submitted in FY 2006 for 133/133 (100%) of NDAs/ANDAs and 15/33
(45%) of BLAs.
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Comissioner for Policy.
[FR Doc. E7-1749 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S