Draft Guidance for Industry on an Amendment Involving Donor Deferral for Transfusion in France Since 1980 to “Guidance for Industry: Revised Preventive Measures to Reduce the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”; Availability, 46484-46485 [E6-13234]
Download as PDF
<![CDATA[
jlentini on PROD1PC65 with NOTICES
46484
Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
4. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Intermediate
Care Facility for the Mentally Retarded
or Persons with Related Conditions ICF/
MR Survey Report Form and Supporting
Regulations at 42 CFR 442.30, 483.410,
483.420, 483.440, 483.50, and 483.460;
Use: The survey forms are needed to
ensure provider compliance. In order to
participate in the Medicaid program as
an ICF/MR, providers must meet
Federal standards. The survey report
form is used to record providers’ level
of compliance with the individual
standard requirements and report it to
the Federal government; Form Number:
CMS–3070G–I (OMB#: 0938–0062);
Frequency: Recordkeeping and
Reporting—Annually; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 6,428; Total Annual
Responses: 6,428; Total Annual Hours:
19,284.
5. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection:
Reconciliation of State Invoice and Prior
Quarter Adjustment Statement; Use:
Section 1927 of the Social Security Act
requires drug labelers to enter into and
have in effect a rebate agreement with
CMS for States to receive funding for
drugs dispensed to Medicaid recipients.
Drug manufacturers must complete and
submit to States the CMS–304 form to
explain any rebate payment adjustments
for the current quarter, and complete
and submit the CMS–304A form to
States to explain rebate payment
adjustments to any prior quarters. Both
forms are used to reconcile drug rebate
payments made by manufacturers with
the States’ invoices of rebates due; Form
Number: CMS–304/304A (OMB#: 0938–
0676); Frequency: Recordkeeping and
Reporting—Quarterly; Affected Public:
Business or other for-profit; Number of
Respondents: 550; Total Annual
Responses: 3,740; Total Annual Hours:
139,480.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s Web site
address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
proposed information collections must
be received at the address below, no
later than 5 p.m. on October 13, 2006.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: August 3, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–13189 Filed 8–11–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1997D–0318] (formerly Docket
No. 97D–0318)
Draft Guidance for Industry on an
Amendment Involving 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’’;
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: 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 CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products,’’’ dated August 2006.
The draft guidance document, when
finalized, is intended to amend FDA’s
‘‘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. This draft guidance,
which is a level I guidance document,
would add to the January 2002 guidance
a donor deferral recommendation for
donors who have received a transfusion
of blood or blood components in France
since 1980. After we review comments
received on this draft guidance, we
intend to incorporate this donor deferral
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
recommendation and reissue the revised
January 2002 guidance as a level II
guidance document for immediate
implementation.
DATES: Submit written or electronic
comments on the draft guidance by
October 13, 2006 to ensure their
adequate consideration in preparation of
the revisions to the 2002 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,
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.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: 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 (Draft Guidance). The Draft
Guidance is intended to amend FDA’s
‘‘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’’ (CJD/
vCJD Guidance), dated January 2002, by
adding a donor deferral
recommendation for donors who have
received a transfusion of blood or blood
components in France since 1980. After
we review comments received on this
Draft Guidance, we intend to
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
jlentini on PROD1PC65 with NOTICES
incorporate this donor deferral
recommendation and reissue the revised
CJD/vCJD Guidance as a level II
guidance document in accordance with
§ 10.115(g)(4)(i) (21 CFR 10.115(g)(4)(i)).
Since the original publication of the
CJD/vCJD Guidance, we have learned of
additional information warranting
revision to the CJD/vCJD Guidance to
address a possible increased risk of
vCJD transmission from individuals
who have received a transfusion of
blood or blood components in France.
This revision is based on:
• The likelihood of exposure to the
Bovine Spongiform Encephalopathy
(BSE) agent in that country and
• The recent documentation of three
presumptive cases of transfusiontransmitted vCJD infection in the United
Kingdom (U.K.).
Because an unknown but possibly
significant number of blood donors
might have already been infected in
France during peak significant years of
the BSE outbreak in Europe, FDA
believes that it would be a prudent
preventive measure to indefinitely defer
all donors (including Source Plasma
donors) who received transfusions of
blood or blood components in France
since 1980.
The Draft Guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 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. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the Draft Guidance at either
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: August 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–13234 Filed 8–11–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0362]
Guidance for Industry on Implementing
a Collection Program for Source
Plasma Containing DiseaseAssociated and Other Immunoglobulin
G (IgG) Antibodies; 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: Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin G (IgG)
Antibodies,’’ dated August 2006. The
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. This guidance
finalizes the draft guidance entitled
‘‘Guidance for Industry:
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin (IgG)
Antibodies,’’ dated October 2005, and
supersedes the draft reviewers’ guide
entitled ‘‘Disease Associated Antibody
Collection Program,’’ dated October 1,
1995.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the 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 guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
46485
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit written comments on the
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 document entitled ‘‘Guidance for
Industry: Implementing a Collection
Program for Source Plasma Containing
Disease-Associated and Other
Immunoglobulin G (IgG) Antibodies’’
dated August 2006. The document
supersedes 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
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.
In the Federal Register of October 20,
2005 (70 FR 61135), FDA announced the
availability of the draft guidance
entitled ‘‘Guidance for Industry:
Recommendations for Implementing a
Collection Program for Source Plasma
Containing Disease-Associated and
Other Immunoglobulin (IgG)
Antibodies’’ dated October 2005. FDA
received one comment on the draft
guidance. However, this comment
related to the guidance process itself,
not to the draft guidance. No changes
other than editorial for clarification
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46484-46485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1997D-0318] (formerly Docket No. 97D-0318)
Draft Guidance for Industry on an Amendment Involving 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'';
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:
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. The draft guidance document, when
finalized, is intended to amend FDA's ``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. This draft
guidance, which is a level I guidance document, would add to the
January 2002 guidance a donor deferral recommendation for donors who
have received a transfusion of blood or blood components in France
since 1980. After we review comments received on this draft guidance,
we intend to incorporate this donor deferral recommendation and reissue
the revised January 2002 guidance as a level II guidance document for
immediate implementation.
DATES: Submit written or electronic comments on the draft guidance by
October 13, 2006 to ensure their adequate consideration in preparation
of the revisions to the 2002 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, 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.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: 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 (Draft Guidance). The
Draft Guidance is intended to amend FDA's ``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'' (CJD/vCJD Guidance), dated
January 2002, by adding a donor deferral recommendation for donors who
have received a transfusion of blood or blood components in France
since 1980. After we review comments received on this Draft Guidance,
we intend to
[[Page 46485]]
incorporate this donor deferral recommendation and reissue the revised
CJD/vCJD Guidance as a level II guidance document in accordance with
Sec. 10.115(g)(4)(i) (21 CFR 10.115(g)(4)(i)).
Since the original publication of the CJD/vCJD Guidance, we have
learned of additional information warranting revision to the CJD/vCJD
Guidance to address a possible increased risk of vCJD transmission from
individuals who have received a transfusion of blood or blood
components in France. This revision is based on:
The likelihood of exposure to the Bovine Spongiform
Encephalopathy (BSE) agent in that country and
The recent documentation of three presumptive cases of
transfusion-transmitted vCJD infection in the United Kingdom (U.K.).
Because an unknown but possibly significant number of blood donors
might have already been infected in France during peak significant
years of the BSE outbreak in Europe, FDA believes that it would be a
prudent preventive measure to indefinitely defer all donors (including
Source Plasma donors) who received transfusions of blood or blood
components in France since 1980.
The Draft Guidance is being issued consistent with FDA's good
guidance practices regulation (Sec. 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. 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.
III. 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: August 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13234 Filed 8-11-06; 8:45 am]
BILLING CODE 4160-01-S
