Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop; Request for Comments, 21270-21271 [E7-8137]
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21270
Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices
the submission of information and
verification of patent information to
ensure not only that the patent contains
drug substance, drug product, or
method of use claims, but that the
patent claims the drug substance, drug
product, or method of using the drug
product for which approval is sought or
has been granted. The clarification that
you have requested would require
revision of FDA’s regulations. FDA will
further consider your request for
clarification and revision to the
regulations in the context of the
rulemaking referenced previously.
Finally, the comment stated that the
submission of FDA Forms 3542a and
3542 with submission and upon
approval, respectively, of an NDA
supplement is redundant where the
information has not changed since the
form last was filed, imposes a burden on
sponsors, and serves no statutory
purpose.
(Response) FDA’s regulation at
§ 314.53(b)(1) requires any applicant
who submits to FDA a supplement to an
approved application that meets the
criteria of § 314.53(d)(2) to submit FDA
Forms 3542a and 3542, as appropriate.
The revision that you have proposed
would require revision of FDA’s
regulations. FDA will further consider
your request for clarification and
revision to the regulations in the context
of the rulemaking referenced previously.
FDA estimates that the collection of
information resulting from these
regulations is as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
FDA Form
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Form FDA 3542a
114
3.2
365
20
7,300
Form FDA 3542
96
3.2
308
5
1,540
Total
1There
8,840
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–8141 Filed 4–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0155]
Defining and Implementing Quality in
Clinical Investigations: From Design to
Completion; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
rwilkins on PROD1PC63 with NOTICES
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
cosponsored with the Drug Information
Association (DIA) entitled ‘‘Defining
and Implementing Quality in Clinical
Investigations: From Design to
Completion.’’ The purpose of the public
workshop is to solicit constructive
information on identifying attributes of
quality in clinical investigations,
approaches to quality from design to
completion, and methods for measuring
quality and ensuring data integrity
during the conduct of clinical
investigations. The public workshop
will discuss the definition of quality,
mechanisms for implementing quality
in clinical investigations, and methods
to improve the accuracy and reliability
of collected data, which will enhance
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18:27 Apr 27, 2007
Jkt 211001
human subject protection. FDA also is
requesting comments on these topics.
Dates and Time: The public workshop
will be held on May 10 and May 11,
2007, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Washington Marriott
Hotel, 1221 22d St. NW., Washington,
DC 20037.
Contact Person: Kathleen Donner,
DIA, 215–293–5810, FAX: 215–442–
6199, or e-mail:
Kathleen.Donner@diahome.org.
Registration: Registration will be
accepted by mail, fax, or e-mail until
May 10, 2007, and also onsite. Mail, fax,
or e-mail your registration information
(including name, title, firm name,
address, telephone, and fax numbers) to
the contact person (see Contact Person).
You may also register online at
www.diahome.org (‘‘Educational
Offerings,’’ keyword 07013). (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) There is a registration fee for
the workshop: $1,165.00 for industry,
$475.00 for charitable nonprofit
organizations or academia, and $200.00
for Federal Government employees. The
registration fees will be used to cover
costs of the workshop, including
program materials and food.
If you need special accommodations
due to a disability, please contact
Kathleen Donner (see Contact Person) at
least 7 days in advance.
Comments: The deadline for
submitting comments regarding this
public workshop is July 10, 2007.
PO 00000
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Sfmt 4703
Interested persons may submit written
or electronic comments to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to
https://www.fda.gov/dockets/ecomments.
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.
SUPPLEMENTARY INFORMATION: The
purpose of the public workshop entitled
‘‘Defining and Implementing Quality in
Clinical Investigations: From Design to
Completion’’ is to solicit constructive
information on identifying attributes of
quality in clinical investigations,
approaches to quality from design to
completion, and methods for measuring
quality and ensuring data integrity
during the conduct of clinical
investigations.
Over time, clinical investigations have
evolved dramatically. In particular,
clinical investigations are no longer
primarily conducted at a single center;
the use of electronic recordkeeping in
the studies has increased dramatically;
and the conduct of clinical
investigations has become more
complex. The public workshop will
address the challenges of and potential
solutions for maintaining quality during
the conduct of clinical investigations to
protect human subjects. The following
E:\FR\FM\30APN1.SGM
30APN1
Federal Register / Vol. 72, No. 82 / Monday, April 30, 2007 / Notices
Dated: April 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–8137 Filed 4–27–07; 8:45 am]
rwilkins on PROD1PC63 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
18:27 Apr 27, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–07–8001]
Memorandum of Understanding
Between the National Cancer Institute
and the Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the National Cancer Institute (NCI), part
of the National Institutes of Health of
the Department of Health and Human
Services. The purpose of this MOU is to
establish a formal collaboration between
FDA and NCI regarding proteomics
science and technology to accelerate
proteomics technology development
and application in clinical settings. FDA
and NCI intend to collaborate in areas
involving proteomics such as: Sample
collection, preparation, storage and
processing; bioinformatics and data
analysis; discovery and validation of
PO 00000
Frm 00070
Fmt 4703
Sfmt 4725
biomarkers; and surrogate biomarkers of
cancer development and drug response,
including standardization among
technology platforms and assay
standards development.
DATES: The agreement became effective
April 5, 2007.
FOR FURTHER INFORMATION CONTACT:
Francis Kalush, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850,
240–276–0996, e-mail:
francis.kalush@fda.hhs.gov.
or Henry Rodriguez, Office of the
Director, (MSC–2580), National
Cancer Institute, 31 Center Dr., rm.
10A52, Bethesda, MD 20892, 301–
496–1550.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: April 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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EN30AP07.017</GPH>
topics will be discussed: (1) The
definition of quality, (2) mechanisms for
implementing quality in clinical
investigations, and (3) methods to
improve the accuracy and reliability of
collected data. As part of the Human
Subject Protection/Bioresearch
Monitoring Initiative (https://
www.fda.gov/ oc/ initiatives/
criticalpath/ ), this public workshop
will help improve the safe conduct of
clinical investigations and maximize
efficiency in clinical investigations
without compromising quality.
21271
]]>Agencies
[Federal Register Volume 72, Number 82 (Monday, April 30, 2007)]
[Notices]
[Pages 21270-21271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0155]
Defining and Implementing Quality in Clinical Investigations:
From Design to Completion; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop cosponsored with the Drug Information Association (DIA)
entitled ``Defining and Implementing Quality in Clinical
Investigations: From Design to Completion.'' The purpose of the public
workshop is to solicit constructive information on identifying
attributes of quality in clinical investigations, approaches to quality
from design to completion, and methods for measuring quality and
ensuring data integrity during the conduct of clinical investigations.
The public workshop will discuss the definition of quality, mechanisms
for implementing quality in clinical investigations, and methods to
improve the accuracy and reliability of collected data, which will
enhance human subject protection. FDA also is requesting comments on
these topics.
Dates and Time: The public workshop will be held on May 10 and May
11, 2007, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Washington
Marriott Hotel, 1221 22d St. NW., Washington, DC 20037.
Contact Person: Kathleen Donner, DIA, 215-293-5810, FAX: 215-442-
6199, or e-mail: Kathleen.Donner@diahome.org.
Registration: Registration will be accepted by mail, fax, or e-mail
until May 10, 2007, and also onsite. Mail, fax, or e-mail your
registration information (including name, title, firm name, address,
telephone, and fax numbers) to the contact person (see Contact Person).
You may also register online at www.diahome.org (``Educational
Offerings,'' keyword 07013). (FDA has verified the Web site address,
but FDA is not responsible for any subsequent changes to the Web site
after this document publishes in the Federal Register.) There is a
registration fee for the workshop: $1,165.00 for industry, $475.00 for
charitable nonprofit organizations or academia, and $200.00 for Federal
Government employees. The registration fees will be used to cover costs
of the workshop, including program materials and food.
If you need special accommodations due to a disability, please
contact Kathleen Donner (see Contact Person) at least 7 days in
advance.
Comments: The deadline for submitting comments regarding this
public workshop is July 10, 2007.
Interested persons may submit written or electronic comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.fda.gov/dockets/ecomments. 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.
SUPPLEMENTARY INFORMATION: The purpose of the public workshop entitled
``Defining and Implementing Quality in Clinical Investigations: From
Design to Completion'' is to solicit constructive information on
identifying attributes of quality in clinical investigations,
approaches to quality from design to completion, and methods for
measuring quality and ensuring data integrity during the conduct of
clinical investigations.
Over time, clinical investigations have evolved dramatically. In
particular, clinical investigations are no longer primarily conducted
at a single center; the use of electronic recordkeeping in the studies
has increased dramatically; and the conduct of clinical investigations
has become more complex. The public workshop will address the
challenges of and potential solutions for maintaining quality during
the conduct of clinical investigations to protect human subjects. The
following
[[Page 21271]]
topics will be discussed: (1) The definition of quality, (2) mechanisms
for implementing quality in clinical investigations, and (3) methods to
improve the accuracy and reliability of collected data. As part of the
Human Subject Protection/Bioresearch Monitoring Initiative (https://
www.fda.gov/oc/initiatives/ criticalpath/ ), this public workshop
will help improve the safe conduct of clinical investigations and
maximize efficiency in clinical investigations without compromising
quality.
Dated: April 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8137 Filed 4-27-07; 8:45 am]
BILLING CODE 4160-01-S
