Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period, 19622 [2014-07898]
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Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Immunogenicity-Related
Considerations for the Approval of Low
Molecular Weight Heparin for NDAs
and ANDAs.’’ This draft guidance
provides recommendations to
applicants for new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs) regarding
impurities and their potential effect on
immunogenicity for LMWH. The draft
guidance also includes
recommendations on meeting the
requirement for active ingredient
sameness for ANDAs. A demonstration
of active ingredient sameness helps to
address immunogenicity in the context
of ANDAs.
This draft guidance is being issued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The draft guidance, when finalized, will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 immunogenicity-related
considerations for low molecular weight
heparin for NDAs and ANDAs. 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.
Dated: April 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07896 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1445]
Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use; Draft Guidance for Industry and
Food and Drug Administration Staff;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
The Food and Drug
Administration (FDA) is extending to
May 7, 2014, the comment period for
the notice that appeared in the Federal
Register of January 7, 2014 (79 FR 830).
In the notice, FDA requested comments
on a draft guidance document entitled
‘‘Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use.’’ The Agency is taking this action
in response to requests for an extension
to allow interested persons additional
time to submit comments.
DATES: FDA is extending the comment
period on the draft guidance entitled
‘‘Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use.’’ Submit either electronic or
written comments by May 7, 2014.
ADDRESSES: Submit electronic
comments on 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. 1601, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5654, Silver Spring,
MD 20993–0002.
SUPPLEMENTARY INFORMATION:
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
I. Background
In the Federal Register of January 7,
2014 (79 FR 830), FDA published a
notice announcing the availability of the
II. The Paperwork Reduction Act of
1995
This guidance refers to a previously
approved collection of information that
is 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 21 CFR part 314 has been
approved under OMB control number
0910–0001.
TKELLEY on DSK3SPTVN1PROD with NOTICES
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
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17:54 Apr 08, 2014
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SUMMARY:
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draft guidance entitled ‘‘Blood Glucose
Monitoring Test Systems for
Prescription Point-of-Care Use.’’
Interested persons were invited to
submit comments by April 7, 2014. At
this time the Agency is extending the
comment period until May 7, 2014, to
continue to receive public comments.
Comments submitted to the docket will
assist in identifying issues to be
addressed in the finalized guidance
document.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07898 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1446]
Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter Use;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending to
May 7, 2014, the comment period for
the notice that appeared in the Federal
Register of January 7, 2014 (79 FR 829).
In the notice, FDA requested comments
on the draft guidance document entitled
‘‘Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter Use.’’ The
Agency is taking this action in response
to requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the draft guidance entitled
‘‘Self-Monitoring Blood Glucose Test
SUMMARY:
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Page 19622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1445]
Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Draft Guidance for Industry and Food and Drug Administration
Staff; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to May 7,
2014, the comment period for the notice that appeared in the Federal
Register of January 7, 2014 (79 FR 830). In the notice, FDA requested
comments on a draft guidance document entitled ``Blood Glucose
Monitoring Test Systems for Prescription Point-of-Care Use.'' The
Agency is taking this action in response to requests for an extension
to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the draft guidance
entitled ``Blood Glucose Monitoring Test Systems for Prescription
Point-of-Care Use.'' Submit either electronic or written comments by
May 7, 2014.
ADDRESSES: Submit electronic comments on 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. 1601, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Patricia Bernhardt, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5654, Silver Spring, MD 20993-0002.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 7, 2014 (79 FR 830), FDA
published a notice announcing the availability of the draft guidance
entitled ``Blood Glucose Monitoring Test Systems for Prescription
Point-of-Care Use.'' Interested persons were invited to submit comments
by April 7, 2014. At this time the Agency is extending the comment
period until May 7, 2014, to continue to receive public comments.
Comments submitted to the docket will assist in identifying issues to
be addressed in the finalized guidance document.
II. Request for Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at https://www.regulations.gov.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07898 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P
