Hemoglobin Based Oxygen Carriers: Current Status and Future Directions; Public Workshop, 7747-7748 [E8-2397]
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Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices
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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 The draft guidance may also be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–
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for electronic access to the draft
guidance document.
Submit written comments on the draft
guidance to the Division of Dockets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.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr. 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: Validation of Growth-Based
Rapid Microbiological Methods for
Sterility Testing of Cellular and Gene
Therapy Products,’’ dated February
2008. This draft guidance applies to
somatic cellular therapy and gene
therapy products. This draft guidance
does not apply directly to human cells,
tissues, and cellular and tissue products
(HCT/Ps) which are regulated solely
under section 361 of the Public Health
Service Act as described under 21 CFR
1271.10, or HCT/Ps which are regulated
as medical devices under 21 CFR part
820. Such products are not subject to
the sterility testing provision in § 610.12
(21 CFR 610.12), or to the requirement
in 21 CFR 610.9 to demonstrate that an
alternative RMM is equivalent to the
sterility method specified in the
regulations. However, HCT/P and
device establishments seeking to
validate an RMM may find these
recommendations useful.
The principles of RMM validation
described in this draft guidance apply
only to growth-based RMMs. Growthbased RMMs, like traditional methods of
detecting viable microorganisms as
described in § 610.12, rely on the ability
to recover and detect organisms from
the product and demonstrate their
viability by multiplication in liquid
media. The specific recommendations
in this document may not be applicable
for non-growth-based RMMs which
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detect microbiological surrogates. This
draft guidance focuses on RMMs with
qualitative results (i.e., detection of
microorganisms). If the RMM does not
have the capability to speciate
microorganisms, an additional method
for speciation will be needed for
investigation of detected contaminants.
Early discussions with product review
staff at CBER are encouraged for
individuals intending to use or develop
an RMM at any time in the product
lifecycle using growth-based, viabilitybased, surrogate-based, or RMMs that
provide quantitative results.
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 to which this draft
guidance refers are covered by 21 CFR
parts 601 (on BLAs) and 312 (on INDs),
and were approved under OMB Control
No. 0910–0338 and 0910–0014,
respectively.
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.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
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7747
Electronic submissions will be accepted
by FDA through FDMS only.
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: January 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2398 Filed 2–8–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Hemoglobin Based Oxygen Carriers:
Current Status and Future Directions;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: Hemoglobin Based Oxygen
Carriers: Current Status and Future
Directions. The purpose of the public
workshop is to discuss the safety of
hemoglobin-based oxygen carriers
(HBOCs) as related to a variety of
potential uses of these investigational
products. We are having this discussion
because clinical and nonclinical studies
of HBOCs, as either blood substitutes or
as resuscitation fluids, have raised
questions about the safety of these
products as a group. The public
workshop will feature presentations and
roundtable discussions led by experts
from academic institutions, government,
and industry.
Date and Time: The public workshop
will be held on April 29, 2008, from
8:30 a.m. to 5 p.m. and April 30, 2008,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Building 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail or fax your
registration information (including
name, title, firm name, address, and
telephone and fax numbers) to the
contact person by April 11, 2008. There
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7748
Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices
is no registration fee for the public
workshop. Early registration is
recommended because seating is limited
to 175 attendees. Registration on the day
of the public workshop will be provided
on a space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson at least 7 days in
advance of the workshop.
FDA; the
National Heart, Lung, and Blood
Institute, National Institutes of Health;
and the Department of Health and
Human Services’ Office of the Secretary
and Office of Public Health and Science
are co-sponsoring this public workshop.
The primary goal of the workshop is to
discuss what is known about the safety
of HBOCs, and possible paths forward
for development of these products.
Topics to be discussed on April 29,
2008, will include: (1) Introduction to
the issues and unmet needs surrounding
HBOC development, (2) overview of the
physiology and chemistry of
hemoglobin in HBOCs, (3) nitric oxide
physiology and pathophysiology related
to HBOCs, (4) review of nonclinical
studies of HBOCs, (5) risk-benefit
considerations in clinical trials of
HBOCs, (6) proposed clinical
indications for HBOCs, and (7)
industry’s experience with HBOC
clinical trials. Panel deliberations on the
safety and efficacy of HBOCs in various
clinical settings and potential
mechanisms of effects on organs will be
the main topics of discussion on April
30, 2008. We also will discuss future
development pathways with a focus on
the use and development of animal
models, biochemical redesign
approaches, and alternative clinical
designs where benefit exceeds risk.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
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16:44 Feb 08, 2008
Jkt 214001
Dated: February 4, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2397 Filed 2–8–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages; Notice of Request for
Nominations
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill five (5)
upcoming vacancies on the Advisory
Committee on Interdisciplinary,
Community-Based Linkages (ACICBL).
Authority: 42 U.S.C. 294f, section 756
of the PHS Act, as amended. The
Advisory Committee is governed by
provisions of Public Law (Pub. L.) 92–
463, as amended (5 U.S.C. Appendix 2)
which sets forth standards for the
formation and use of advisory
committees.
The Agency must receive
nominations on or before March 12,
2008.
DATES:
All nominations are to be
submitted by mail to Louis D.
Coccodrilli, Designated Federal Official,
ACICBL, Bureau of Health Professions
(BHPr), HRSA, Parklawn Building,
Room 9–05, 5600 Fishers Lane;
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Adriana Guerra, Public Health Fellow,
Division of Medicine and Dentistry, by
e-mail aguerra@hrsa.gov or telephone,
(301) 443–6194.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the ACICBL,
the Federal Advisory Committee Act of
October 6, 1972 (Pub. L. 92–463), and
section 2119 of the Act, 42 U.S.C. 00aa–
19, as added by Pub. L. 99–660 and
amended, HRSA is requesting
nominations for five (5) voting
members.
The ACICBL provides advice and
recommendations to the Secretary and
to the Congress concerning policy,
program development and other matters
of significance related to
interdisciplinary, community-based
training grant programs authorized
under sections 751–756, Title VII, Part
ADDRESSES:
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D of the Public Health Service Act. The
ACICBL prepares an annual report
describing the activities conducted
during the fiscal year, identifying
findings and developing
recommendations to enhance Title VII
Interdisciplinary, Community-Based
Training Grant Programs. The Annual
Report is submitted to the Secretary of
the U.S. Department of Health and
Human Services, and ranking members
of the Committee on Health, Education,
Labor and Pensions of the Senate, and
the Committee on Energy and
Commerce of the House of
Representatives.
The Department of Health and Human
Services is requesting a total of five (5)
nominations for voting members of the
ACICBL from schools that have
administered or are currently
administering awards from the
following programs: Allied Health—one
(1) nominee, Geriatric Education and
Training Programs—one (1) nominee,
and Health Education and Training
Centers (HETCs)—one (1) nominee.
Nominations are also requested for two
(2) students, residents, and/or fellow
representatives.
The legislation governing this
Committee requires a fair balance of
health professionals who represent the
general population with regard to a
broad geographic distribution and an
evenness of urban and rural areas, along
with professionals who are women and
minorities. As such, the pool of
appropriately qualified nominations
should reflect these requirements to the
degree possible.
Interested individuals may nominate
multiple qualified professionals for
membership to the ACICBL to allow the
Secretary a diverse listing of highly
qualified potential candidates.
Nominees willing to serve as members
of the ACICBL should not have an
appearance of a conflict of interest that
would preclude their participation.
Potential candidates will be asked to
provide detailed information concerning
consultancies, research grants, or
contracts to permit an evaluation of
possible sources of conflicts of interest.
In addition, a curriculum vitae and a
statement of interest will be required of
the nominee to support experience
working with Title VII Interdisciplinary,
Community-Based Training Grant
Programs, expertise in the field, and
personal desire in participating on a
National Advisory Committee. Qualified
candidates will be invited to serve a two
or three-year term. All nominations
must be received no later than March
12, 2008.
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]]>Agencies
[Federal Register Volume 73, Number 28 (Monday, February 11, 2008)]
[Notices]
[Pages 7747-7748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2397]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Hemoglobin Based Oxygen Carriers: Current Status and Future
Directions; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: Hemoglobin Based Oxygen Carriers: Current Status and
Future Directions. The purpose of the public workshop is to discuss the
safety of hemoglobin-based oxygen carriers (HBOCs) as related to a
variety of potential uses of these investigational products. We are
having this discussion because clinical and nonclinical studies of
HBOCs, as either blood substitutes or as resuscitation fluids, have
raised questions about the safety of these products as a group. The
public workshop will feature presentations and roundtable discussions
led by experts from academic institutions, government, and industry.
Date and Time: The public workshop will be held on April 29, 2008,
from 8:30 a.m. to 5 p.m. and April 30, 2008, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Lister Hill
Center Auditorium, Building 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail or fax your registration information (including
name, title, firm name, address, and telephone and fax numbers) to the
contact person by April 11, 2008. There
[[Page 7748]]
is no registration fee for the public workshop. Early registration is
recommended because seating is limited to 175 attendees. Registration
on the day of the public workshop will be provided on a space available
basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson at least 7 days in advance of the workshop.
SUPPLEMENTARY INFORMATION: FDA; the National Heart, Lung, and Blood
Institute, National Institutes of Health; and the Department of Health
and Human Services' Office of the Secretary and Office of Public Health
and Science are co-sponsoring this public workshop. The primary goal of
the workshop is to discuss what is known about the safety of HBOCs, and
possible paths forward for development of these products. Topics to be
discussed on April 29, 2008, will include: (1) Introduction to the
issues and unmet needs surrounding HBOC development, (2) overview of
the physiology and chemistry of hemoglobin in HBOCs, (3) nitric oxide
physiology and pathophysiology related to HBOCs, (4) review of
nonclinical studies of HBOCs, (5) risk-benefit considerations in
clinical trials of HBOCs, (6) proposed clinical indications for HBOCs,
and (7) industry's experience with HBOC clinical trials. Panel
deliberations on the safety and efficacy of HBOCs in various clinical
settings and potential mechanisms of effects on organs will be the main
topics of discussion on April 30, 2008. We also will discuss future
development pathways with a focus on the use and development of animal
models, biochemical redesign approaches, and alternative clinical
designs where benefit exceeds risk.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: February 4, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2397 Filed 2-8-08; 8:45 am]
BILLING CODE 4160-01-S
