Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Availability, 41080-41081 [07-3659]
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41080
Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
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Annual Application ...........................
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61
61
1
1
25
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Dated: July 20, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14439 Filed 7–25–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee for Injury
Prevention and Control (ACIPC),
Science and Program Review
Subcommittee
rwilkins on PROD1PC63 with NOTICES
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces, the following meeting for
the aforementioned committee and
subcommittee:
Name: Science and Program Review
Subcommittee (SPRS).
Times and Date: 11:30 a.m.–11:35 a.m.,
August 20, 2007 (Open). 11:35 a.m.–12:30
p.m., August 20, 2007 (Closed).
Place: CDC, Koger Center, Vanderbilt
Building, Room 1006, 2939 Flowers Road,
Atlanta, Georgia 30341–3724.
Purpose: The subcommittee provides
advice on the needs, structure, progress, and
performance of programs in the National
Center for Injury Prevention and Control
(NCIPC).
Matters To Be Discussed: The
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discussion, and evaluation on the individual
research grant and cooperative agreement
applications submitted in response to the two
Fiscal Year 2007 Requests for Applications
(RFAs) related to the following individual
research announcements: RFA–CE–05–020,
Youth Violence Prevention through
Community-Level Change; and RFA–CE–07–
011, Multi-Level Parent Training
Effectiveness Trial—Phase II (U49).
Following this meeting, the voting
members of ACIPC will meet via
teleconference to vote on the
recommendations of the SPRS regarding the
RFAs.
VerDate Aug<31>2005
16:36 Jul 25, 2007
Jkt 211001
Name: Advisory Committee for Injury
Prevention and Control.
Times and Date: 12:30 p.m.–12:55 p.m.,
August 20, 2007 (Open). 12:55 p.m.–1:30
p.m., August 20, 2007 (Closed).
Place: CDC, Koger Center, Vanderbilt
Building, Room 1006, 2939 Flowers Road,
Atlanta, Georgia 30341–3724.
Purpose: The committee advises and makes
recommendations to the Secretary,
Department of Health and Human Services,
the Director, CDC, and the Director, NCIPC
regarding feasible goals for the prevention
and control of injury. The committee makes
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results of the secondary review. This portion
of the meeting will be closed to the public
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the Determination of the Acting Director,
Management Analysis and Services Office,
CDC pursuant to Public Law 92–463.
Agenda items are subject to change as
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For Further Information Contact: Ms. Amy
Harris, Executive Secretary, ACIPC, NCIPC,
CDC, 4770 Buford Highway, NE., M/S K61,
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both CDC and the Agency for Toxic
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Dated: July 17, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–14430 Filed 7–25–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0290]
Draft Guidance for Industry: Cell
Selection Devices for Point of Care
Production of Minimally Manipulated
Autologous Peripheral Blood Stem
Cells; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Cell Selection
Devices for Point of Care Production of
Minimally Manipulated Autologous
Peripheral Blood Stem Cells (PBSCs)’’
dated July 2007. The draft guidance
document discusses certain cell
selection devices that minimally
manipulate autologous PBSCs at the
point of care for specific clinical
indications, and the applicability of the
requirements to such PBSCs. The
guidance also discusses the submission
of data intended to support approval of
cell selection devices.
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 October 24, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
E:\FR\FM\26JYN1.SGM
26JYN1
Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
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 https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Cell Selection Devices for
Point of Care Production of Minimally
Manipulated Autologous Peripheral
Blood Stem Cells (PBSCs)’’ dated July
2007. The draft guidance document
discusses certain cell selection devices
that minimally manipulate autologous
PBSCs at the point of care for specific
clinical indications, and the
applicability of the requirements of 21
CFR part 1271 to such PBSCs. The
guidance also discusses the submission
of data intended to support approval of
cell selection devices.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’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 requirement
of the applicable statutes and
regulations.
rwilkins on PROD1PC63 with NOTICES
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 812 have
been approved under 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
0910–0231; the collections of
information in 21 CFR part 820 have
been approved under 0910–0073; and
the collections of information in 21 CFR
part 822 have been approved under
0910–0449.
16:36 Jul 25, 2007
Jkt 211001
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–3659 Filed 7–23–07; 12:02 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0347]
Draft Guidance for Industry and Food
and Drug Administration Staff; In Vitro
Diagnostic Multivariate Index Assays;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
entitled ‘‘In Vitro Diagnostic
Multivariate Index Assays.’’ FDA is
issuing this revised draft guidance to
address the definition and regulatory
status of a class of In Vitro Diagnostic
Devices referred to as In Vitro
Diagnostic Multivariate Index Assays
(IVDMIAs). The revised draft guidance
also addresses premarket and
postmarket requirements with respect to
IVDMIAs. The initial draft of this
guidance was issued September 7, 2006.
DATES: Submit written or electronic
comments on this draft guidance by
August 27, 2007.
PO 00000
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Fmt 4703
Submit written requests for
single copies of the draft guidance
document entitled ‘‘In Vitro Diagnostic
Multivariate Index Assays’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850 or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the draft guidance.
Submit written comments concerning
this 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 https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Courtney Harper, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0694.
For further information concerning
the guidance as it related to devices
regulated by CBER: Martin Ruta, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–3518.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. 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 the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
ACTION:
II. Paperwork Reduction Act of 1995
VerDate Aug<31>2005
III. Comments
41081
Sfmt 4703
I. Background
In the Federal Register of September
7, 2006 (71 FR 52800). FDA published
a notice of availability of the initial draft
guidance to address the definition and
regulatory status of a class of in vitro
diagnostic devices referred to as ‘‘In
Vitro Diagnostic Multivariate Index
Assays (IVDMIAs).’’ The initial draft
guidance also addressed premarket and
postmarket requirements with respect to
IVDMIAs.
An IVDMIA, as defined in the draft
guidance document, is a device within
the meaning of the Federal Food, Drug,
and Cosmetic Act (the act). Some
IVDMIAs are laboratory-developed tests
(LDTs); laboratory-developed IVDMIAs
are a specific subset of LDTs. While
FDA has stated that ‘‘clinical
laboratories that develop (in-house) tests
E:\FR\FM\26JYN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 143 (Thursday, July 26, 2007)]
[Notices]
[Pages 41080-41081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0290]
Draft Guidance for Industry: Cell Selection Devices for Point of
Care Production of Minimally Manipulated Autologous Peripheral Blood
Stem Cells; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry: Cell
Selection Devices for Point of Care Production of Minimally Manipulated
Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007. The
draft guidance document discusses certain cell selection devices that
minimally manipulate autologous PBSCs at the point of care for specific
clinical indications, and the applicability of the requirements to such
PBSCs. The guidance also discusses the submission of data intended to
support approval of cell selection devices.
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
October 24, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-
[[Page 41081]]
800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
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 https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Cell Selection Devices for Point of Care
Production of Minimally Manipulated Autologous Peripheral Blood Stem
Cells (PBSCs)'' dated July 2007. The draft guidance document discusses
certain cell selection devices that minimally manipulate autologous
PBSCs at the point of care for specific clinical indications, and the
applicability of the requirements of 21 CFR part 1271 to such PBSCs.
The guidance also discusses the submission of data intended to support
approval of cell selection devices.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA'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 requirement of the applicable statutes
and regulations.
II. 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 812 have been approved under
0910-0078; the collections of information in 21 CFR part 814 have been
approved under 0910-0231; the collections of information in 21 CFR part
820 have been approved under 0910-0073; and the collections of
information in 21 CFR part 822 have been approved under 0910-0449.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. 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 the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-3659 Filed 7-23-07; 12:02 pm]
BILLING CODE 4160-01-S
