Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies; Availability, 16311-16312 [E8-6210]
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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Data collection mode
Total burden
hours
Average hourly wage rate*
Total cost
burden
Post-intervention survey of clinicians and staff(2) ...........................................
Control survey of clinicians and staff(2) ..........................................................
Chart audits(3) .................................................................................................
Patient Focus Groups (post-intervention)(1) ...................................................
20
5
25
80
50
12.5
208.33
160
28
28
10
12.54
1,400
350
2,083.33
2,006.40
Total ..........................................................................................................
7,740
1,978.33
........................
29,844.73
(1) Patient average hourly wage based
on the average per capita income of
$26,088 (computed into an hourly wage
rate of $12.54) in Lehigh Valley,
Pennsylvania: ‘‘Demographic
Information for the Lehigh Valley’’ from
the Lehigh Valley Economic
Development Corporation 2006.
(2) Provider and practice hourly wage
based on an average of the following
estimates from LVPHO: physician =
$70/hour; manager = $19/hour; clinical
staff = $13/hour; and clerical staff =
$10/hour.
(3) Practice clerical staff will retrieve
the charts to be audited by study
personnel; therefore only the time of the
practice staff is included in Exhibit 1
and in the Exhibit 2 cost estimate.
Practice clerical staff hourly wage is
estimated by LVPHO to be $10/hour.
Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
government is $271,764.68. The average
annualized cost over the two years of
the project is $135,882.34 per year.
Exhibit 3 shows a breakdown of the
costs.
EXHIBIT 3.—ESTIMATED ANNUAL COSTS TO THE FEDERAL GOVERNMENT
Component
Year 1
Year 2
Total
The cost of developing the data collection instruments ..............................................................
The cost of implementing the data collections ............................................................................
The cost of analyzing the data and publishing the results .........................................................
$24,765.38
99,061.52
49,530.76
$0
24,601.75
73,805.26
$24,765.38
123,663.27
123,336.02
Total ......................................................................................................................................
173,357.66
98,407.02
271,764.68
pwalker on PROD1PC71 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Aug<31>2005
17:27 Mar 26, 2008
Jkt 214001
Dated: March 20, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–6073 Filed 3–26–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0180]
Draft Guidance for Industry on
Coronary Drug Eluting Stents–
Nonclinical and Clinical Studies;
Availability
AGENCY:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Coronary Drug
Eluting Stents—Nonclinical and
Clinical Studies.’’ This draft guidance is
intended to provide recommendations
to sponsors or applicants planning to
develop, or to submit to FDA, a
marketing application for a coronary
drug eluting stent (DES). The draft
guidance discusses the clinical studies
PO 00000
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 25, 2008.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to
ADDRESSES:
HHS.
ACTION:
that should be performed and the data
that should be submitted to support
such an application. The draft guidance
is being issued in two parts. The
companion document provides
additional and more detailed guidance
on some of the recommendations
included in this document. The
companion document is intended to be
used together with this draft guidance.
Frm 00067
Fmt 4703
Sfmt 4703
E:\FR\FM\27MRN1.SGM
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16312
Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Devices and
Radiological Health (HFZ–450),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–4222, or
Devi Kozeli, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4183,
Silver Spring, MD 20903–0002,
301–796–1128.
SUPPLEMENTARY INFORMATION:
I. Background
pwalker on PROD1PC71 with NOTICES
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Coronary Drug Eluting Stents—
Nonclinical and Clinical Studies.’’
Coronary stents are implantable devices
that are placed percutaneously in one or
more coronary arteries to maintain
patency. As defined by section 503(g) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353(g)), DESs are
considered combination products
because they are a combination of two
different types of regulated components
(a device and a drug) that are physically
and/or chemically combined and
produced as a single entity (21 CFR
3.2(e)(1)). A combination product is
assigned to an agency component, such
as the Center for Devices and
Radiological Health (CDRH) or the
Center for Drug Evaluation and Research
(CDER) for premarket review and
regulation based on a determination of
the product’s primary mode of action. In
response to several requests for
designation under 21 CFR 3.7, the
agency determined that the primary
mode of action for current DESs is that
of the device component in maintaining
coronary artery patency; the drug
component plays a secondary role in
preventing restenosis, augmenting the
safety and/or effectiveness of the
uncoated (bare) stent.1 Therefore, the
premarket review and regulatory
responsibility has been assigned to
CDRH. Nevertheless, careful
consideration should be given to
1 See ‘‘Jurisdictional Update: Drug-Eluting
Cardiovascular Stents,’’ https://www.fda.gov/oc/
combination/stents.html. This Jurisdictional Update
is applicable to DESs for which the primary mode
of action is the device component in maintaining
vessel patency. However, a DES for which the
primary mode of action is attributable to the drug
component would be assigned to CDER.
VerDate Aug<31>2005
17:27 Mar 26, 2008
Jkt 214001
characterizing the drug component of
DESs. This draft guidance is intended to
provide recommendations on meeting
the regulatory requirements for both the
drug and device components of a DES.
DESs incorporate a pharmacologically
active agent (drug) that is delivered at
the site of stent deployment to reduce
the incidence of restenosis due to
neointimal hyperplasia associated with
bare metal stenting. In many cases, the
drug is incorporated into and released
from a polymeric coating of sufficient
capacity to accommodate the selected
dose and to modulate its delivery at the
intended site of action and for the
intended duration. The chemical,
physical, and mechanical attributes of
the polymer coating system are
important for stent deployment,
biocompatibility, and stability. To
perform a regulatory assessment of a
DES, FDA must review data from a
comprehensive evaluation of individual
components (drug, polymer, and stent),
as well as from a comprehensive
evaluation of the finished drug-device
combination product.
This draft guidance clarifies a number
of issues related to the development
DESs including the following.
• How to characterize the drug
substance, including chemistry,
nonclinical systemic and local tissue
pharmacology and toxicology, and how
to evaluate potential for and
consequences of systemic clinical
exposure.
• How to characterize the drug-device
combination product, including the
chemical/physical/mechanical
properties of the DES, the nonclinical
local vascular and regional myocardial
toxicology, and the clinical performance
of the drug-stent combination.
• Regulatory considerations that are
unique to DES combination products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 211
(current good manufacturing practice for
finished pharmaceuticals) have been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR parts 312
(investigational new drug application)
and 314 (applications for FDA approval
to market a new drug) have been
approved under OMB control numbers
0910–0014 and 0910–0001. The
collections of information in FDA’s
medical devices regulations in 21 CFR
parts 801 (labeling), 803 (medical device
reporting), 812 (investigational device
exemptions), 814 (premarket approval of
medical devices), and 820 (quality
system regulation) have been approved
under OMB control numbers 0910–
0485, 0910–0437, 0910–0078, 0910–
0231, and 0910–0073.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6210 Filed 3–26–08; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 60 (Thursday, March 27, 2008)]
[Notices]
[Pages 16311-16312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6210]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0180]
Draft Guidance for Industry on Coronary Drug Eluting Stents-
Nonclinical and Clinical Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Coronary Drug
Eluting Stents--Nonclinical and Clinical Studies.'' This draft guidance
is intended to provide recommendations to sponsors or applicants
planning to develop, or to submit to FDA, a marketing application for a
coronary drug eluting stent (DES). The draft guidance discusses the
clinical studies that should be performed and the data that should be
submitted to support such an application. The draft guidance is being
issued in two parts. The companion document provides additional and
more detailed guidance on some of the recommendations included in this
document. The companion document is intended to be used together with
this draft guidance.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 25, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to
[[Page 16312]]
https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-4222, or
Devi Kozeli, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4183, Silver
Spring, MD 20903-0002, 301-796-1128.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Coronary Drug Eluting Stents--Nonclinical and Clinical
Studies.'' Coronary stents are implantable devices that are placed
percutaneously in one or more coronary arteries to maintain patency. As
defined by section 503(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(g)), DESs are considered combination products because
they are a combination of two different types of regulated components
(a device and a drug) that are physically and/or chemically combined
and produced as a single entity (21 CFR 3.2(e)(1)). A combination
product is assigned to an agency component, such as the Center for
Devices and Radiological Health (CDRH) or the Center for Drug
Evaluation and Research (CDER) for premarket review and regulation
based on a determination of the product's primary mode of action. In
response to several requests for designation under 21 CFR 3.7, the
agency determined that the primary mode of action for current DESs is
that of the device component in maintaining coronary artery patency;
the drug component plays a secondary role in preventing restenosis,
augmenting the safety and/or effectiveness of the uncoated (bare)
stent.\1\ Therefore, the premarket review and regulatory responsibility
has been assigned to CDRH. Nevertheless, careful consideration should
be given to characterizing the drug component of DESs. This draft
guidance is intended to provide recommendations on meeting the
regulatory requirements for both the drug and device components of a
DES.
---------------------------------------------------------------------------
\1\ See ``Jurisdictional Update: Drug-Eluting Cardiovascular
Stents,'' https://www.fda.gov/oc/combination/stents.html. This
Jurisdictional Update is applicable to DESs for which the primary
mode of action is the device component in maintaining vessel
patency. However, a DES for which the primary mode of action is
attributable to the drug component would be assigned to CDER.
---------------------------------------------------------------------------
DESs incorporate a pharmacologically active agent (drug) that is
delivered at the site of stent deployment to reduce the incidence of
restenosis due to neointimal hyperplasia associated with bare metal
stenting. In many cases, the drug is incorporated into and released
from a polymeric coating of sufficient capacity to accommodate the
selected dose and to modulate its delivery at the intended site of
action and for the intended duration. The chemical, physical, and
mechanical attributes of the polymer coating system are important for
stent deployment, biocompatibility, and stability. To perform a
regulatory assessment of a DES, FDA must review data from a
comprehensive evaluation of individual components (drug, polymer, and
stent), as well as from a comprehensive evaluation of the finished
drug-device combination product.
This draft guidance clarifies a number of issues related to the
development DESs including the following.
How to characterize the drug substance, including
chemistry, nonclinical systemic and local tissue pharmacology and
toxicology, and how to evaluate potential for and consequences of
systemic clinical exposure.
How to characterize the drug-device combination product,
including the chemical/physical/mechanical properties of the DES, the
nonclinical local vascular and regional myocardial toxicology, and the
clinical performance of the drug-stent combination.
Regulatory considerations that are unique to DES
combination products.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 211 (current good
manufacturing practice for finished pharmaceuticals) have been approved
under OMB control number 0910-0139. The collections of information in
21 CFR parts 312 (investigational new drug application) and 314
(applications for FDA approval to market a new drug) have been approved
under OMB control numbers 0910-0014 and 0910-0001. The collections of
information in FDA's medical devices regulations in 21 CFR parts 801
(labeling), 803 (medical device reporting), 812 (investigational device
exemptions), 814 (premarket approval of medical devices), and 820
(quality system regulation) have been approved under OMB control
numbers 0910-0485, 0910-0437, 0910-0078, 0910-0231, and 0910-0073.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: March 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6210 Filed 3-26-08; 8:45 am]
BILLING CODE 4160-01-S
