Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability, 14024-14025 [2011-5945]
Download as PDF
<![CDATA[
14024
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ROCEPHIN (ceftriaxone
sodium) Injection, 250mg, 500mg, 1g,
2g, and 10g base/vial, approved under
NDA 050585, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
withdrawn from sale for reasons other
than safety or effectiveness. ANDAs that
refer to any of the products described in
this notice may be approved by FDA as
long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for any of these drug products
should be revised to meet current
standards, the Agency will advise
ANDA applicants to submit such
labeling.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5947 Filed 3–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0104]
Draft Guidance for Industry on NonPenicillin Beta-Lactam Risk
Assessment: A CGMP Framework;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Non-Penicillin BetaLactam Risk Assessment: A CGMP
Framework.’’ This guidance describes
the importance of implementing
appropriate steps during the
manufacturing process to prevent crosscontamination of finished
pharmaceuticals and active
pharmaceutical ingredients (APIs) with
non-penicillin beta-lactam antibiotics.
The draft guidance is intended to assist
manufacturers in assessing whether
separate facilities should be used based
on the relative health risk of crossreactivity.
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considers your comment on this draft
guidance before it begins work on the
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:50 Mar 14, 2011
Jkt 223001
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 16, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm.
2201, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request. The guidance may also be
obtained by mail by calling CDER at
301–796–3400. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments
concerning the draft guidance 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.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Edwin Melendez, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4370,
Silver Spring, MD 20993–0002, 301–
796–3284.
SUPPLEMENTARY INFORMATION:
following types of cross-contamination:
(1) Non-penicillin beta-lactam
contamination in a non-beta-lactam
product (e.g., cefaclor in aspirin) and (2)
non-penicillin beta-lactam
contamination in another non-penicillin
beta-lactam (e.g., cephalexin in
imipenem).
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 non-penicillin beta-lactam risk
assessment. 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
requirements of the applicable statute
and regulations.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Non-Penicillin Beta-Lactam Risk
Assessment: A CGMP Framework.’’ This
draft guidance describes the importance
of implementing appropriate steps
during the manufacturing process to
prevent cross-contamination of finished
pharmaceuticals and APIs with nonpenicillin beta-lactam antibiotics. It also
provides information regarding the
relative health risk of, and the potential
for, cross-reactivity in the classes of
sensitizing beta-lactams (penicillins and
non-penicillin beta-lactams).
Drug cross-contamination is the
contamination of one drug with one or
more different drugs. Crosscontamination with non-penicillin betalactam drugs can initiate drug-induced
hypersensitivity reactions, including
anaphylaxis, an allergic reaction that
may be a life-threatening event. One
critical aspect of manufacturing nonpenicillin beta-lactam drugs is
preventing cross-contamination to
reduce the potential for drug-induced,
life-threatening allergic reactions. FDA
is recommending that manufacturers
establish appropriate separation and
control systems designed to prevent the
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5948 Filed 3–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0150]
Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\15MRN1.SGM
15MRN1
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
availability of a guidance for industry
entitled ‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims.’’ This guidance is intended to
assist applicants in developing labeling
for outcome claims for drugs that are
indicated to treat hypertension. With
few exceptions, current labeling for
antihypertensive drugs includes only
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 Agency 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.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance 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: 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:
srobinson on DSKHWCL6B1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Hypertension Indication: Drug Labeling
for Cardiovascular Outcome Claims.’’
The intent of the guidance is to provide
common labeling for antihypertensive
drugs except where differences are
clearly supported by clinical data. With
publication of this guidance, applicants
are encouraged to submit labeling
VerDate Mar<15>2010
16:50 Mar 14, 2011
Jkt 223001
supplements containing the new
language.
A draft guidance of the same title was
announced in the Federal Register on
March 13, 2008 (73 FR 13546), and
Docket No. FDA–2008–D–0150 was
open for comments until May 12, 2008.
Comments received from industry,
professional societies, and consumer
groups on the draft guidance were taken
into consideration by FDA in finalizing
this guidance. Throughout the guidance,
the language has been condensed and
simplified to be more concise and clear.
A section has been added to clarify
procedures for obtaining approval of
new labeling and its applicability to
advertising. The guidance describes
how applicants can provide clinical
evidence for any drugs they perceive to
be missing from Table 1, Approved
Drugs for Chronic Treatment of
Hypertension, by submitting the
information to the docket number listed
in brackets in the heading of this
document. The division will review the
information and revise the guidance to
include any new labeling changes
supported by clinical data submitted to
the docket.
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 labeling for
cardiovascular outcome claims for drugs
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
requirements of the applicable statutes
and regulations.
II. The 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 of information in
this guidance was approved under OMB
control number 0910–0670.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
14025
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5945 Filed 3–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0568]
Guidance for Industry on Planning for
the Effects of High Absenteeism To
Ensure Availability of Medically
Necessary Drug Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Planning for the Effects of High
Absenteeism to Ensure Availability of
Medically Necessary Drug Products.’’
The guidance encourages manufacturers
of medically necessary drug products
(MNPs) and components to develop
production plans in the event of an
emergency that results in high
absenteeism at one or more production
facilities. The purpose of the guidance
is to provide to industry considerations
for developing plans for these types of
emergencies, as well as to discuss the
Center for Drug Evaluation and
Research’s (CDER’s) intended approach
to assist in avoiding drug product
shortages that may have a negative
impact on the national public health
during such emergencies.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this 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 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
SUMMARY:
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14024-14025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5945]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0150]
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
[[Page 14025]]
availability of a guidance for industry entitled ``Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This
guidance is intended to assist applicants in developing labeling for
outcome claims for drugs that are indicated to treat hypertension. With
few exceptions, current labeling for antihypertensive drugs includes
only 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 Agency 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.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this 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 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to
http:[sol][sol]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: 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 guidance for industry
entitled ``Hypertension Indication: Drug Labeling for Cardiovascular
Outcome Claims.'' The intent of the guidance is to provide common
labeling for antihypertensive drugs except where differences are
clearly supported by clinical data. With publication of this guidance,
applicants are encouraged to submit labeling supplements containing the
new language.
A draft guidance of the same title was announced in the Federal
Register on March 13, 2008 (73 FR 13546), and Docket No. FDA-2008-D-
0150 was open for comments until May 12, 2008. Comments received from
industry, professional societies, and consumer groups on the draft
guidance were taken into consideration by FDA in finalizing this
guidance. Throughout the guidance, the language has been condensed and
simplified to be more concise and clear. A section has been added to
clarify procedures for obtaining approval of new labeling and its
applicability to advertising. The guidance describes how applicants can
provide clinical evidence for any drugs they perceive to be missing
from Table 1, Approved Drugs for Chronic Treatment of Hypertension, by
submitting the information to the docket number listed in brackets in
the heading of this document. The division will review the information
and revise the guidance to include any new labeling changes supported
by clinical data submitted to the docket.
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 labeling for cardiovascular outcome claims
for drugs 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 requirements of the applicable statutes and regulations.
II. The 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 of information in this guidance was approved under OMB
control number 0910-0670.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http:[sol][sol]www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
http:[sol][sol]www.regulations.gov.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5945 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P
