Identifying the Center for Drug Evaluation and Research's Science and Research Needs; Availability of a Draft Report; Request for Comments, 44593-44594 [2011-18880]
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Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices
500), Food and Drug Administration,
5630 Fishers Lane, rm. 1078, Rockville,
MD 20857, 301–827–7175, e-mail:
gladys.Melendez-bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–16120, appearing on page 37817,
in the Federal Register of Tuesday, June
28, 2011, the following correction is
made:
1. On page 37819, in third column,
section A. Award Amount is corrected
to read as follows:
The total funding available is up to
$360,000 (total costs including indirect
costs) in fiscal year 2011 in support of
this project. One award will be made.
Funding will be provided for one year,
with the possibility of up to four
additional years of support, contingent
upon successful performance and
available funding.
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18881 Filed 7–25–11; 8:45 am]
BILLING CODE 4160–01–P
Submit written requests for
single copies of this report 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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft report.
Submit electronic comments on the
draft report to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4540,
Silver Spring, MD 20993–0002, 301–
796–2600.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0239]
Identifying the Center for Drug
Evaluation and Research’s Science
and Research Needs; Availability of a
Draft Report; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft report entitled
‘‘Identifying CDER’s Science and
Research Needs.’’ This document
identifies current priorities in regulatory
science related to the mission of the
Center for Drug Evaluation and Research
(CDER), and will guide strategic
planning of internal research efforts.
Through external communication of the
science and research needs outlined in
the report, CDER hopes to stimulate
research and foster collaborations with
external partners and stakeholders to
address these priorities.
DATES: Although you can comment on
the report at any time, to ensure that the
Agency considers your comment on this
report before it begins work on the final
version of the report, submit either
electronic or written comments on the
report by September 26, 2011.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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16:12 Jul 25, 2011
Jkt 223001
FDA is announcing the availability of
a draft report entitled ‘‘Identifying
CDER’s Science and Research Needs.’’
This report is the result of an effort to
identify regulatory science needs that, if
addressed, would enhance CDER’s
ability to fulfill its regulatory mission. A
publication entitled ‘‘FDA Critical Path
Opportunities Report and Critical Path
Opportunities List’’ was published in
March 2006. That report focused on the
scientific challenges underlying medical
product development and served as a
catalyst for CDER to launch an effort to
identify specific areas that would
benefit from additional regulatory
science efforts. More recently, FDA
released, ‘‘Advancing Regulatory
Science for Public Health’’, which
incorporates the Critical Path objectives
into a broad framework for advancing
regulatory science. In support of these
initiatives, this report delineates major
areas of scientific need that can
contribute to the development of a
strategic science and research agenda.
To begin an assessment of these
needs, more than 200 representatives
from CDER’s offices were asked to
identify: (1) Scientific challenges
currently addressed on a case-by-case
basis that might benefit from the
development of a systematized
approach; (2) recurrent science issues
across teams, divisions, or offices; and
(3) emerging scientific challenges. A
comprehensive set of science and
research needs was compiled from these
discussions. Senior management from
PO 00000
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Fmt 4703
Sfmt 4703
44593
CDER offices reviewed and prioritized
topics from their offices. These science
and research needs were ultimately
grouped into seven categories that were
reviewed and endorsed by the CDER
Science Prioritization and Review
Committee and CDER senior
management.
Seven major categories that crossed
multiple disciplines were identified: (1)
Improve access to postmarket data
sources and explore feasibility of their
use in different types of analyses; (2)
improve risk assessment and
management strategies to reinforce the
safe use of drugs; (3) evaluate the
effectiveness and impact of different
types of regulatory communications to
the public and other stakeholders; (4)
evaluate the links among product
quality attributes, manufacturing
processes, and product performance; (5)
develop and improve predictive models
of safety and efficacy in humans; (6)
improve clinical trial design, analysis,
and conduct; and (7) enhance
individualization of patient treatment.
The draft report is not intended to
address the need to maintain a robust
scientific readiness to respond rapidly
to regulatory crises, but by
communicating CDER’s current science
and research needs, CDER hopes to
stimulate research and foster
collaborations with external partners
and stakeholders. CDER is
disseminating this document externally
and soliciting input on: (1) Research and
initiatives that may be ongoing; and (2)
opportunities to collaborate with
external partners and stakeholders to
maximize resources to address the areas
for development discussed previously.
The input will be reviewed and
incorporated as appropriate into plans
for collaborations and potential external
partners will be contacted for further
discussion.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov.
E:\FR\FM\26JYN1.SGM
26JYN1
44594
Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ann
H. Costello, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2460, Silver Spring,
MD 20993–0002, 301–796–6493.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2011–D–0465]
This guidance document will serve as
the special control for rTMS systems.
Section 513(f)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) provides that any
person who submits a premarket
notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) for a device
that has not previously been classified
may, within 30 days after receiving an
order classifying the device in class III
under section 513(f)(1) of the FD&C Act,
request FDA to classify the device under
the criteria set forth in section 513(a)(1)
of the FD&C Act. FDA will, within 60
days of receiving such a request, classify
the device by written order. This
classification will be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
announcing this classification. Because
of the timeframes established by section
513(f)(2) of the FD&C Act, FDA has
determined, under 21 CFR 10.115(g)(2),
that it is not feasible to allow for public
participation before issuing this
guidance as a final guidance document.
Thus, FDA is issuing this guidance
document as a level 1 guidance
document that is for immediate
implementation. FDA will consider any
comments that are received in response
to this notice to determine whether to
revise the guidance document.
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying rTMS systems into class II
(special controls), under section
513(f)(2) of the FD&C Act.
[FR Doc. 2011–18880 Filed 7–25–11; 8:45 am]
BILLING CODE 4160–01–P
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Repetitive Transcranial Magnetic
Stimulation Systems; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Repetitive Transcranial
Magnetic Stimulation Systems.’’ This
guidance document describes a means
by which a repetitive transcranial
magnetic stimulation (rTMS) system
may comply with the requirement of
special controls for class II devices. This
guidance document is being
immediately implemented as the special
control for rTMS systems, but it remains
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Repetitive
Transcranial Magnetic Stimulation
Systems’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:12 Jul 25, 2011
Jkt 223001
II. Significance of Special Controls
Guidance
FDA believes that adherence to the
recommendations described in this
guidance, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of rTMS systems classified under
882.5805 (21 CFR 882.5805). In order to
be classified as a class II device under
882.5805, a rTMS system must comply
with the requirements of special
controls; manufacturers must address
the issues requiring special controls as
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identified in the guidance document,
either by following the
recommendations in the guidance
document or by some other means that
provides equivalent assurances of safety
and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
To receive ‘‘Class II Special Controls
Guidance Document: Repetitive
Transcranial Magnetic Stimulation
(rTMS) Systems’’ you may either send
an e-mail request to dsmica@fda.hhs.gov
to receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a paper copy.
Please use the document number 1728
to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This 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 807 subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; and the collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44593-44594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0239]
Identifying the Center for Drug Evaluation and Research's Science
and Research Needs; Availability of a Draft Report; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft report entitled ``Identifying CDER's Science
and Research Needs.'' This document identifies current priorities in
regulatory science related to the mission of the Center for Drug
Evaluation and Research (CDER), and will guide strategic planning of
internal research efforts. Through external communication of the
science and research needs outlined in the report, CDER hopes to
stimulate research and foster collaborations with external partners and
stakeholders to address these priorities.
DATES: Although you can comment on the report at any time, to ensure
that the Agency considers your comment on this report before it begins
work on the final version of the report, submit either electronic or
written comments on the report by September 26, 2011.
ADDRESSES: Submit written requests for single copies of this report 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. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft report.
Submit electronic comments on the draft report to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4540,
Silver Spring, MD 20993-0002, 301-796-2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft report entitled
``Identifying CDER's Science and Research Needs.'' This report is the
result of an effort to identify regulatory science needs that, if
addressed, would enhance CDER's ability to fulfill its regulatory
mission. A publication entitled ``FDA Critical Path Opportunities
Report and Critical Path Opportunities List'' was published in March
2006. That report focused on the scientific challenges underlying
medical product development and served as a catalyst for CDER to launch
an effort to identify specific areas that would benefit from additional
regulatory science efforts. More recently, FDA released, ``Advancing
Regulatory Science for Public Health'', which incorporates the Critical
Path objectives into a broad framework for advancing regulatory
science. In support of these initiatives, this report delineates major
areas of scientific need that can contribute to the development of a
strategic science and research agenda.
To begin an assessment of these needs, more than 200
representatives from CDER's offices were asked to identify: (1)
Scientific challenges currently addressed on a case-by-case basis that
might benefit from the development of a systematized approach; (2)
recurrent science issues across teams, divisions, or offices; and (3)
emerging scientific challenges. A comprehensive set of science and
research needs was compiled from these discussions. Senior management
from CDER offices reviewed and prioritized topics from their offices.
These science and research needs were ultimately grouped into seven
categories that were reviewed and endorsed by the CDER Science
Prioritization and Review Committee and CDER senior management.
Seven major categories that crossed multiple disciplines were
identified: (1) Improve access to postmarket data sources and explore
feasibility of their use in different types of analyses; (2) improve
risk assessment and management strategies to reinforce the safe use of
drugs; (3) evaluate the effectiveness and impact of different types of
regulatory communications to the public and other stakeholders; (4)
evaluate the links among product quality attributes, manufacturing
processes, and product performance; (5) develop and improve predictive
models of safety and efficacy in humans; (6) improve clinical trial
design, analysis, and conduct; and (7) enhance individualization of
patient treatment.
The draft report is not intended to address the need to maintain a
robust scientific readiness to respond rapidly to regulatory crises,
but by communicating CDER's current science and research needs, CDER
hopes to stimulate research and foster collaborations with external
partners and stakeholders. CDER is disseminating this document
externally and soliciting input on: (1) Research and initiatives that
may be ongoing; and (2) opportunities to collaborate with external
partners and stakeholders to maximize resources to address the areas
for development discussed previously. The input will be reviewed and
incorporated as appropriate into plans for collaborations and potential
external partners will be contacted for further discussion.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov.
[[Page 44594]]
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18880 Filed 7-25-11; 8:45 am]
BILLING CODE 4160-01-P
