Draft Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability, 13546-13547 [E8-5083]
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Federal Register / Vol. 73, No. 50 / Thursday, March 13, 2008 / Notices
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respondent
Average
burden hours
per response
Total burden
hours
Title IV–E State Plan .......................................................................................
12
1
15
180
Estimated Total Annual Burden
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information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 5, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–4805 Filed 3–12–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2008–D–0150]
Draft Guidance for Industry on
Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
16:19 Mar 12, 2008
Jkt 214001
ACTION:
I. Background
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims.’’ This
draft guidance is intended to assist
applicants in developing labeling for
cardiovascular outcome claims for drugs
that are indicated to treat hypertension.
Because blood pressure control is well
established as beneficial in preventing
serious cardiovascular events, FDA
believes that the appropriate use of
these drugs can be encouraged by
making the connection between lower
blood pressure and improved
cardiovascular outcomes more explicit
in labeling. This draft guidance is
intended to recommend standard
labeling for antihypertensive drugs
except where differences are clearly
supported by clinical data.
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 byMay 12, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your requests.
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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
SUMMARY:
Devi
Kozeli, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 4183, Silver Spring,
MD 20993–0002, 301–796–1128.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims.’’ On June 15, 2005, the
Cardiovascular and Renal Drugs
Advisory Committee met in open public
session to discuss class labeling for
cardiovascular outcome claims for drugs
that are indicated to treat hypertension.
With few exceptions, current labeling
for antihypertensive drug products only
includes the information that these
drugs are indicated to reduce blood
pressure; the labeling does not include
information on the clinical benefits
related to cardiovascular outcomes
expected from such blood pressure
reduction. However, blood pressure
control is well established as beneficial
in preventing serious cardiovascular
events, and inadequate treatment of
hypertension is acknowledged as a
significant public health problem. The
committee voiced a broad consensus in
favor of labeling changes to describe
briefly the clinical benefits related to
cardiovascular outcomes expected from
lowering blood pressure with any
antihypertensive drug. The labeling
proposed in this draft guidance is
consistent with the advisory
committee’s recommendations.
This draft guidance is being made
available to afford the public the
opportunity to comment on both the
intent of the labeling revisions and the
specific proposed language. This draft
guidance is intended to recommend
standard labeling for antihypertensive
drugs except where differences are
clearly supported by clinical data. After
this guidance has been finalized,
applicants will be encouraged to submit
labeling supplements containing the
new language.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on labeling for cardiovascular outcome
claims for drugs indicated to treat
hypertension. 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\13MRN1.SGM
13MRN1
Federal Register / Vol. 73, No. 50 / Thursday, March 13, 2008 / Notices
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 regarding this document.
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. Received
comments may be seen 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.
Electronic submissions will be accepted
by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–5083 Filed 3–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; Revision to
Existing System of Records; Revised
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notification of an Altered
System of Records; revised.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act, the
Health Resources and Services
Administration (HRSA) is publishing
notice of a proposal to alter the system
of records for the C.W. Bill Young Cell
Transplantation Program. This system of
records is required to comply with the
implementation directives of Public
Law 109–129. Records are used for the
C.W. Bill Young Cell Transplantation
Program’s planning, implementation,
evaluation, monitoring, and document
storage purposes.
HRSA published in the Federal
Register of August 17, 2007, a document
VerDate Aug<31>2005
16:19 Mar 12, 2008
Jkt 214001
concerning notice of a new system of
records, 09–15–0068, C.W. Bill Young
Cell Transplantation Program (FR. Doc.
07–4019). This document more fully
explains the routine uses of records
maintained in the system and amends
the record retention and disposal policy.
Accordingly, the notice is published
below in its entirety, as amended.
DATES: Persons wishing to comment on
this revised system of records notice
may do so until April 14, 2008. Unless
there is a further notice in the Federal
Register, this revised system of records
will become effective on April 14, 2008.
ADDRESSES: Please address comments to
Health Resources and Services
Administration Privacy Act
Coordinator, Donn Taylor, 5600 Fishers
Lane, Room 14A–20, Rockville,
Maryland 20857; telephone (301) 443–
0204. This is not a toll-free number.
Comments received will be available for
inspection at this same address from 9
a.m. to 3 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
James F. Burdick, M.D., Director,
Division of Transplantation, HSB,
HRSA, 5600 Fishers Lane, Room 12C–
06, Rockville, Maryland 20857;
telephone (301) 443–7577; fax (301)
594–6095; or e-mail: jburdick@hrsa.gov.
This is not a toll-free number.
SUPPLEMENTARY INFORMATION: The
Health Resources and Services
Administration published in the
Federal Register of August 17, 2007,
notice of a new system of records, 09–
15–0068, C.W. Bill Young Cell
Transplantation Program. The Stem Cell
Therapeutic and Research Act of 2005
(the Act) establishes the C.W. Bill
Young Cell Transplantation Program
(the Program) which maintains
information related to patients in need
of a blood stem cell transplant and
potential adult volunteer blood stem
cell donors who have agreed to be listed
on the registry maintained by the
Program. Additionally, the Program
maintains information related to the
outcomes of patients who have
undergone blood stem cell
transplantation.
The Stem Cell Therapeutic and
Research Act of 2005 authorizes the
C.W. Bill Young Cell Transplantation
Program and provides for the collection,
maintenance, and distribution of human
blood stem cells for the treatment of
patients and for research. The Program
consists of four interrelated components
each operated under a separate contract.
The four components are: the Bone
Marrow Coordinating Center; the Cord
Blood Coordinating Center; the Office of
Patient Advocacy/Single Point of
Access; and the Stem Cell Therapeutic
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
13547
Outcomes Database. The contracts for
operation of the Bone Marrow
Coordinating Center, Cord Blood
Coordinating Center, and Office of
Patient Advocacy/Single Point of Access
were awarded to the National Marrow
Donor Program in September 2006. A
single contract for the Stem Cell
Therapeutic Outcomes Database was
awarded to the Center for International
Blood and Marrow Transplant Research
(CIBMTR) at the Medical College of
Wisconsin in September 2006 as well.
As identified by the Act, the Program
is charged with: Operating a system for
identifying, matching, and facilitating
the distribution of bone marrow that is
suitably matched to candidate patients;
operating a system for identifying,
matching, and facilitating the
distribution of donated umbilical cord
blood units that are suitably matched to
candidate patients; providing a means
by which transplant physicians, other
healthcare professionals, and patients
can electronically search for and access
all available adult marrow donors
available through the Program;
recruiting potential adult volunteer
marrow donors; coordinating with other
Federal programs to maintain and
expand medical contingency response
capabilities; carrying out informational
and educational activities; providing
patient advocacy services; providing
case management services for potential
donors; and collecting, analyzing, and
publishing blood stem cell
transplantation related data, including
patient outcomes data, in a standardized
electronic format. This system of
records is required to comply with the
implementation directives of the Act,
Public Law 109–129. The records will
be used for the C.W. Bill Young Cell
Transplantation Program’s planning,
implementation, evaluation, monitoring,
and document storage purposes.
Dated: February 19, 2008.
Elizabeth M. Duke,
Administrator.
09–15–0068
SYSTEM NAME:
C.W. Bill Young Cell Transplantation
Program.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Data collected by the C.W. Bill Young
Cell Transplantation Program (the
Program) are maintained by the National
Marrow Donor Program (NMDP) and the
Medical College of Wisconsin,
contractors for the Program. The
Division of Transplantation within the
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 73, Number 50 (Thursday, March 13, 2008)]
[Notices]
[Pages 13546-13547]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5083]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0150]
Draft Guidance for Industry on Hypertension Indication: Drug
Labeling for Cardiovascular Outcome Claims; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This
draft guidance is intended to assist applicants in developing labeling
for cardiovascular outcome claims for drugs that are indicated to treat
hypertension. Because blood pressure control is well established as
beneficial in preventing serious cardiovascular events, FDA believes
that the appropriate use of these drugs can be encouraged by making the
connection between lower blood pressure and improved cardiovascular
outcomes more explicit in labeling. This draft guidance is intended to
recommend standard labeling for antihypertensive drugs except where
differences are clearly supported by clinical data.
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
byMay 12, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
requests. 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. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Devi Kozeli, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4183, Silver Spring, MD 20993-0002, 301-
796-1128.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Hypertension Indication: Drug Labeling for Cardiovascular
Outcome Claims.'' On June 15, 2005, the Cardiovascular and Renal Drugs
Advisory Committee met in open public session to discuss class labeling
for cardiovascular outcome claims for drugs that are indicated to treat
hypertension. With few exceptions, current labeling for
antihypertensive drug products only includes the information that these
drugs are indicated to reduce blood pressure; the labeling does not
include information on the clinical benefits related to cardiovascular
outcomes expected from such blood pressure reduction. However, blood
pressure control is well established as beneficial in preventing
serious cardiovascular events, and inadequate treatment of hypertension
is acknowledged as a significant public health problem. The committee
voiced a broad consensus in favor of labeling changes to describe
briefly the clinical benefits related to cardiovascular outcomes
expected from lowering blood pressure with any antihypertensive drug.
The labeling proposed in this draft guidance is consistent with the
advisory committee's recommendations.
This draft guidance is being made available to afford the public
the opportunity to comment on both the intent of the labeling revisions
and the specific proposed language. This draft guidance is intended to
recommend standard labeling for antihypertensive drugs except where
differences are clearly supported by clinical data. After this guidance
has been finalized, applicants will be encouraged to submit labeling
supplements containing the new language.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on labeling for
cardiovascular outcome claims for drugs indicated to treat
hypertension. 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 13547]]
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 regarding this document.
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. Received comments may be seen 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. Electronic submissions will
be accepted by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: March 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5083 Filed 3-12-08; 8:45 am]
BILLING CODE 4160-01-S
