Draft Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin Antibodies; Availability, 61135-61136 [05-20958]
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Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of September
13, 2004 (69 FR 55163), FDA published
a notice announcing the availability of
a draft tripartite guidance entitled ‘‘E14
Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic
Drugs.’’ The notice gave interested
persons an opportunity to submit
comments by December 13, 2004. In
response to a request for additional time
to comment, FDA reopened the
comment period until February 18, 2005
(70 FR 823, January 5, 2005). On April
11 and 12, 2005, FDA, the Drug
Information Association, and the Heart
Rhythm Society cosponsored a public
meeting to discuss the draft guidance.
Comments received at the meeting were
made available to the Efficacy Expert
Working Group. After consideration of
the comments received and revisions to
the guidance, a final draft of the
guidance was submitted to the ICH
Steering Committee and endorsed by the
three participating regulatory agencies
in May 2005.
The guidance provides guidance on
the design, conduct, analysis and
interpretation of clinical studies to
assess the potential of a new drug to
cause cardiac arrhythmias, focusing on
the assessment of changes in the QT/
QTc interval on the electrocardiogram
as a predictor of risk. The guidance is
intended to encourage the assessment of
drug effects on the QT/QTc interval,
along with the collection of adverse
cardiac events related to arrhythmias, as
a standard part of drug development,
and to encourage the early discussion of
this assessment with the FDA. The goal
of such discussions is to reach a
common understanding of the effects as
early in development as practical, with
the goal of enhancing the efficiency of
data collection later in drug
development. The guidance
incorporates the following changes: (1)
A fuller discussion of the factors that
influence the clinical assessment of
drug effects on the QT interval and (2)
an adjustment in the statistical analysis
of QT interval data obtained as a part of
early thorough QT assessment.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
VerDate Aug<31>2005
16:14 Oct 19, 2005
Jkt 208001
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at anytime.
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. The guidance
and 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.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20971 Filed 10–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0362]
Draft Guidance for Industry on
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin Antibodies;
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:
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin (IgG)
Antibodies,’’ dated October 2005. The
draft guidance document is intended to
assist source plasma manufacturers in
submitting to FDA the appropriate
information when implementing an IgG
antibody collection program or when
adding a new IgG antibody collection to
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
61135
an existing program. The draft guidance,
when finalized, would supersede the
draft reviewers’ guide entitled ‘‘Disease
Associated Antibody Collection
Program,’’ dated October 1, 1995.
DATES: Submit written or electronic
comments on the draft guidance by
January 18, 2006 to ensure their
adequate consideration in preparation of
the final guidance. General comments
on agency guidance documents are
welcome at any time.
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,
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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, 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: Recommendations for
Implementing a Collection Program for
Source Plasma Containing DiseaseAssociated and Other Immunoglobulin
(IgG) Antibodies’’ dated October 2005.
The draft guidance, when finalized,
would supersede the draft reviewers’
guide, ‘‘Disease Associated Antibody
Collection Program,’’ dated October 1,
1995. The document provides guidance
to source plasma manufacturers in
submitting the appropriate information
to FDA when implementing an IgG
antibody collection program or when
adding a new IgG antibody collection to
an existing program. The guidance
identifies changes in collection
programs that must be documented as
minor changes in an annual report to
FDA under § 601.12(d) (21 CFR
601.12(d)). These collection programs
include disease-associated IgG
E:\FR\FM\20OCN1.SGM
20OCN1
61136
Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
antibodies and other existing IgG
antibodies. The guidance also identifies
labeling changes to be submitted as a
supplement for changes being effected
under § 601.12(f)(2)(i)(E). The guidance
neither includes recommendations
related to implementing
Immunoglobulin M antibody collection
programs, nor does it include
recommendations for donors who do
not meet all donor suitability
requirements under 21 CFR 640.63.
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 guidance contains information
collection provisions that 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 collection(s) of information
in this guidance was approved under
OMB control number 0910–0338.
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 written or electronic
comments to ensure adequate
consideration in preparation of the final
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: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20958 Filed 10–19–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Program Exclusions: September 2005
AGENCY:
Office of Inspector General,
HHS.
ACTION:
Notice of program exclusions.
During the month of September 2005,
the HHS Office of Inspector General
imposed exclusions in the cases set
forth below. When an exclusion is
imposed, no program payment is made
to anyone for any items or services
(other than an emergency item or
service not provided in a hospital
emergency room) furnished, ordered or
prescribed by an excluded party under
the Medicare, Medicaid, and all Federal
Health Care programs. In addition, no
program payment is made to any
business or facility, e.g., a hospital, that
submits bills for payment for items or
services provided by an excluded party.
Program beneficiaries remain free to
decide for themselves whether they will
continue to use the services of an
excluded party even though no program
payments will be made for items and
services provided by that excluded
party. The exclusions have national
effect and also apply to all Executive
Branch procurement and nonprocurement programs and activities.
Subject name
Address
Program-Related Convictions:
Agopian, Ovsanna .................................................................................................
Altidor, Rejeanne ...................................................................................................
Andino, Rosario .....................................................................................................
Arnold, David .........................................................................................................
Arthur Avenue Pharmacy ......................................................................................
Bagley, Barbara ....................................................................................................
Barragan, Elian .....................................................................................................
Barrett, Nadine ......................................................................................................
Blumberg, Gary .....................................................................................................
Brailsford, Philip ....................................................................................................
Brown, Roger ........................................................................................................
Burleson, Delpha ...................................................................................................
Butts, Frank ...........................................................................................................
Cansler, Ronnie ....................................................................................................
Cardio Diagnostic Technology & Consultants, Inc ...............................................
Celestin, Andre ......................................................................................................
Central Community Service, Inc ...........................................................................
Chaffin, Alisa .........................................................................................................
Choi, Ricardo ........................................................................................................
Cifelli, Charles .......................................................................................................
Cifelli, Darren ........................................................................................................
Cifelli, Karen ..........................................................................................................
Clark, Harry ...........................................................................................................
Clark, Shirley .........................................................................................................
Collins, Monique ....................................................................................................
Davidson, Lee .......................................................................................................
Davis, James .........................................................................................................
Du, Danny .............................................................................................................
Estevez, Maria ......................................................................................................
Fabian, Misty .........................................................................................................
Flanigan, George ..................................................................................................
Flores, William .......................................................................................................
Granada Hills, CA .....................................
Elmont, NY ................................................
Miami, FL ..................................................
Athens, PA ................................................
Bronx, NY .................................................
Los Angeles, CA .......................................
Bronx, NY .................................................
Bronx, NY .................................................
Deerfield, FL .............................................
Escondido, CA ..........................................
Trenton, NJ ...............................................
Purcell, OK ................................................
Texarkana, TX ..........................................
Los Angeles, CA .......................................
Westerville, OH .........................................
Elmont, NY ................................................
Los Angeles, CA .......................................
Lansing, MI ...............................................
Miami, FL ..................................................
The Villages, FL ........................................
West Yarmouth, MA .................................
West Yarmouth, MA .................................
Pensacola, FL ...........................................
Vallejo, CA ................................................
New Orleans, LA ......................................
Los Angeles, CA .......................................
Irving, TX ..................................................
Wasco, CA ................................................
Coleman, FL .............................................
Timpson, TX .............................................
Los Angeles, CA .......................................
Los Angeles, CA .......................................
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]]>Agencies
[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Notices]
[Pages 61135-61136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0362]
Draft Guidance for Industry on Recommendations for Implementing a
Collection Program for Source Plasma Containing Disease-Associated and
Other Immunoglobulin Antibodies; 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:
Recommendations for Implementing a Collection Program for Source Plasma
Containing Disease-Associated and Other Immunoglobulin (IgG)
Antibodies,'' dated October 2005. The draft guidance document is
intended to assist source plasma manufacturers in submitting to FDA the
appropriate information when implementing an IgG antibody collection
program or when adding a new IgG antibody collection to an existing
program. The draft guidance, when finalized, would supersede the draft
reviewers' guide entitled ``Disease Associated Antibody Collection
Program,'' dated October 1, 1995.
DATES: Submit written or electronic comments on the draft guidance by
January 18, 2006 to ensure their adequate consideration in preparation
of the final guidance. General comments on agency guidance documents
are welcome at any time.
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, 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, 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: Recommendations for Implementing a Collection
Program for Source Plasma Containing Disease-Associated and Other
Immunoglobulin (IgG) Antibodies'' dated October 2005. The draft
guidance, when finalized, would supersede the draft reviewers' guide,
``Disease Associated Antibody Collection Program,'' dated October 1,
1995. The document provides guidance to source plasma manufacturers in
submitting the appropriate information to FDA when implementing an IgG
antibody collection program or when adding a new IgG antibody
collection to an existing program. The guidance identifies changes in
collection programs that must be documented as minor changes in an
annual report to FDA under Sec. 601.12(d) (21 CFR 601.12(d)). These
collection programs include disease-associated IgG
[[Page 61136]]
antibodies and other existing IgG antibodies. The guidance also
identifies labeling changes to be submitted as a supplement for changes
being effected under Sec. 601.12(f)(2)(i)(E). The guidance neither
includes recommendations related to implementing Immunoglobulin M
antibody collection programs, nor does it include recommendations for
donors who do not meet all donor suitability requirements under 21 CFR
640.63.
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 guidance contains information collection provisions that 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
collection(s) of information in this guidance was approved under OMB
control number 0910-0338.
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
written or electronic comments to ensure adequate consideration in
preparation of the final 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: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20958 Filed 10-19-05; 8:45 am]
BILLING CODE 4160-01-S
