Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Availability, 29768-29769 [2010-12696]
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29768
Federal Register / Vol. 75, No. 102 / Thursday, May 27, 2010 / Notices
• Cancer industry is predicted to
expand to $85.3 billion by 2010.
Inventors: Hui Han and John E.
Niederhuber (NCI).
Patent Status: U.S. Provisional
Application No. 61/253,617 filed 21 Oct
2009 (HHS Reference No. E–303–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Dated: May 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–12790 Filed 5–26–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1997–D–0008] (formerly
Docket No. 1997D–0318)
Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’ dated
May 2010. The guidance announced in
this notice provides blood collecting
establishments and manufacturers of
plasma derivatives with comprehensive
FDA recommendations intended to
minimize the possible risk of
transmission of CJD and vCJD from
blood and blood products. This
guidance document amends the January
2002 guidance document of the same
title by: Incorporating donor deferral
recommendations for donors who have
received a transfusion of blood or blood
components in France since 1980,
providing updated scientific
information on CJD and vCJD, revising
labeling recommendations for Whole
Blood and blood components intended
for transfusion, and recognizing AABB’s
full Donor History Questionnaire
VerDate Mar<15>2010
15:26 May 26, 2010
Jkt 220001
Version 1.3 as an acceptable mechanism
for collection of donor history
information. The guidance announced
in this notice supersedes the guidance
document entitled ‘‘Guidance for
Industry: Revised Preventive Measures
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products’’ dated January 2002
(2002 guidance), and the draft guidance
document entitled ‘‘Draft Guidance for
Industry: Amendment (Donor Deferral
for Transfusion in France Since 1980) to
‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’’ dated
August 2006 (2006 draft guidance).
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (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 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 guidance
document.
Submit electronic or written
comments on the guidance. Submit
electronic comments 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:
´
Denise Sanchez, 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 document entitled ‘‘Guidance for
Industry: Revised Preventive Measures
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products’’ dated May 2010. This
guidance amends the 2002 FDA
guidance of the same title by
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
incorporating donor deferral
recommendations as to donors in France
(as announced in the 2006 draft
guidance), providing updated scientific
information on CJD and vCJD, revising
labeling recommendations for Whole
Blood and blood components intended
for transfusion, and recognizing the use
of AABB’s full Donor History
Questionnaire Version 1.3 as an
acceptable mechanism that is consistent
with FDA requirements and
recommendations for collecting donor
history information.
In the Federal Register of January 16,
2002 (67 FR 2226), FDA announced the
availability of a guidance entitled
‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’ dated
January 2002 (the 2002 guidance). The
2002 guidance finalized
recommendations to all blood collecting
establishments and manufacturers of
plasma derivatives for deferral of donors
with possible exposure to the CJD and
vCJD agents. In the Federal Register of
August 14, 2006 (71 FR 46484), FDA
announced the availability of a draft
guidance entitled ‘‘Draft Guidance for
Industry: Amendment (Donor Deferral
for Transfusion in France Since 1980) to
‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’’ (the 2006
draft guidance). The 2006 draft guidance
was intended to amend the 2002
guidance by adding a donor deferral
recommendation for donors who have
received a transfusion of blood or blood
components in France since 1980.
Specifically, in the 2006 draft guidance,
we stated that we intended to
incorporate the new donor deferral
recommendation after receiving
comments on the draft guidance and
reissue the revised 2002 guidance as a
level 2 guidance document for
immediate implementation (71 FR
46484, August 14, 2006). Upon further
consideration, however, we believe it
appropriate to issue the guidance
announced in this notice as a level 1
guidance document.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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
E:\FR\FM\27MYN1.SGM
27MYN1
Federal Register / Vol. 75, No. 102 / Thursday, May 27, 2010 / Notices
requirements of the applicable statutes
and regulations.
II. 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 601.12 have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
606.100 have been approved under
OMB control number 0910–0116; and
the collections of information in 21 CFR
Part 600.14 and 606.171 have been
approved under OMB control number
0910–0458.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) electronic
or written comments regarding the
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
brackets in the heading of this
document. A copy of the 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 guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: May 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–12696 Filed 5–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
wwoods2 on DSK1DXX6B1PROD with NOTICES
Agency for Healthcare Research and
Quality
Notice of Meetings
In accordance with section 10(d) of
the Federal Advisory Committee Act as
amended (5 U.S.C., Appendix 2), the
Agency for Healthcare Research and
Quality (AHRQ) announces meetings of
scientific peer review groups. The
subcommittees listed below are part of
VerDate Mar<15>2010
15:26 May 26, 2010
Jkt 220001
the Agency’s Health Services Research
Initial Review Group Committee.
The subcommittee meetings will be
closed to the public in accordance with
the Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications are to be reviewed and
discussed at these meetings. These
discussions are likely to involve
information concerning individuals
associated with the applications,
including assessments of their personal
qualifications to conduct their proposed
projects. This information is exempt
from mandatory disclosure under the
above-cited statutes.
1. Name of Subcommittee: Health Care
Technology and Decision Sciences.
Date: June 15–17, 2010 (Open from 8 a.m.
to 8:15 a.m. on June 15 and closed for
remainder of the meeting)
Place: Crowne Plaza Hotel, 3 Research
Court, Conference Room TBD, Rockville, MD
20852.
2. Name of Subcommittee: Health Systems
Research.
Date: June 16–18, 2010 (Open from 8 a.m.
to 8:15 a.m. on June 16 and closed for
remainder of the meeting)
Place: Sheraton Rockville Hotel, 920 King
Farm Boulevard, Conference Room TBD,
Rockville, MD 20852.
3. Name of Subcommittee: Health Care
Research Training.
Date: June 17–18, 2010 (Open from 8 a.m.
to 8:15 a.m. on June 17 and closed for
remainder of the meeting)
Place: Hyatt Regency Hotel, 7400
Wisconsin Avenue, 1 Bethesda Metro Center,
Conference Room TBD, Bethesda, Maryland
20814.
4. Name of Subcommittee: Health Care
Quality and Effectiveness Research.
Date: June 22–24, 2010 (Open from 8:30
a.m. to 8:45 a.m. on June 22 and closed for
remainder of the meeting)
Place: Hilton Rockville Executive Meeting
Center, 1750 Rockville Pike, Conference
Room TBD, Rockville, Maryland 20850.
Contact Person: Anyone wishing to obtain
a roster of members, agenda or minutes of the
nonconfidential portions of the meetings
should contact Mrs. Bonnie Campbell,
Committee Management Officer, Office of
Extramural Research, Education and Priority
Populations, AHRQ, 540 Gaither Road, Suite
2000, Rockville, Maryland 20850, Telephone
(301) 427–1554.
Agenda items for these meetings are
subject to change as priorities dictate.
Dated: May 13, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–12547 Filed 5–26–10; 8:45 am]
BILLING CODE 4160–90–M
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29769
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Integrating
Patient-Reported Outcomes in Hospice and
Palliative Care Practices.
Date: June 1, 2010.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute, 6116
Executive Blvd., Room 8018, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Shamala K. Srinivas, PhD,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Boulevard, Room 8123,
Bethesda, MD 20892, 301–594–1224,
ss537t@nih.gov.
This notice is being published less than 30
days prior to the meeting due to scheduling
conflicts.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Development of Anticancer Agents.
Date: June 2, 2010.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Room 8018, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Joyce C. Pegues, B.S., B.A.,
PhD, Scientific Review Officer, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Boulevard,
Room 7149, Bethesda, MD 20892–8329,
301–594–1286, peguesj@mail.nih.gov.
This notice is being published less than 30
days prior to the meeting due to scheduling
conflicts.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
E:\FR\FM\27MYN1.SGM
27MYN1
Agencies
[Federal Register Volume 75, Number 102 (Thursday, May 27, 2010)]
[Notices]
[Pages 29768-29769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12696]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1997-D-0008] (formerly Docket No. 1997D-0318)
Guidance for Industry: Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Revised
Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products'' dated May 2010. The guidance
announced in this notice provides blood collecting establishments and
manufacturers of plasma derivatives with comprehensive FDA
recommendations intended to minimize the possible risk of transmission
of CJD and vCJD from blood and blood products. This guidance document
amends the January 2002 guidance document of the same title by:
Incorporating donor deferral recommendations for donors who have
received a transfusion of blood or blood components in France since
1980, providing updated scientific information on CJD and vCJD,
revising labeling recommendations for Whole Blood and blood components
intended for transfusion, and recognizing AABB's full Donor History
Questionnaire Version 1.3 as an acceptable mechanism for collection of
donor history information. The guidance announced in this notice
supersedes the guidance document entitled ``Guidance for Industry:
Revised Preventive Measures to Reduce the Possible Risk of Transmission
of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob
Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002
guidance), and the draft guidance document entitled ``Draft Guidance
for Industry: Amendment (Donor Deferral for Transfusion in France Since
1980) to ``Guidance for Industry: Revised Preventive Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD)
and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood
Products''' dated August 2006 (2006 draft guidance).
DATES: Submit electronic or written comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (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 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 guidance document.
Submit electronic or written comments on the guidance. Submit
electronic comments 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: Denise S[aacute]nchez, 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 document entitled
``Guidance for Industry: Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
dated May 2010. This guidance amends the 2002 FDA guidance of the same
title by incorporating donor deferral recommendations as to donors in
France (as announced in the 2006 draft guidance), providing updated
scientific information on CJD and vCJD, revising labeling
recommendations for Whole Blood and blood components intended for
transfusion, and recognizing the use of AABB's full Donor History
Questionnaire Version 1.3 as an acceptable mechanism that is consistent
with FDA requirements and recommendations for collecting donor history
information.
In the Federal Register of January 16, 2002 (67 FR 2226), FDA
announced the availability of a guidance entitled ``Guidance for
Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant
Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated
January 2002 (the 2002 guidance). The 2002 guidance finalized
recommendations to all blood collecting establishments and
manufacturers of plasma derivatives for deferral of donors with
possible exposure to the CJD and vCJD agents. In the Federal Register
of August 14, 2006 (71 FR 46484), FDA announced the availability of a
draft guidance entitled ``Draft Guidance for Industry: Amendment (Donor
Deferral for Transfusion in France Since 1980) to `Guidance for
Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant
Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''' (the
2006 draft guidance). The 2006 draft guidance was intended to amend the
2002 guidance by adding a donor deferral recommendation for donors who
have received a transfusion of blood or blood components in France
since 1980. Specifically, in the 2006 draft guidance, we stated that we
intended to incorporate the new donor deferral recommendation after
receiving comments on the draft guidance and reissue the revised 2002
guidance as a level 2 guidance document for immediate implementation
(71 FR 46484, August 14, 2006). Upon further consideration, however, we
believe it appropriate to issue the guidance announced in this notice
as a level 1 guidance document.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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
[[Page 29769]]
requirements of the applicable statutes and regulations.
II. 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 601.12 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
606.100 have been approved under OMB control number 0910-0116; and the
collections of information in 21 CFR Part 600.14 and 606.171 have been
approved under OMB control number 0910-0458.
III. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) electronic or written comments
regarding the 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 brackets in the heading of this document. A copy of the
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 guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: May 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12696 Filed 5-26-10; 8:45 am]
BILLING CODE 4160-01-S