Draft Guidance for Industry on Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for New Drug Applications and Abbreviated New Drug Applications; Availability, 19621-19622 [2014-07896]
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Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
of Honey and Honey Products.’’ FDA
developed this draft guidance to advise
firms on the proper labeling of honey
and honey products to help ensure that
honey and honey products are not
adulterated or misbranded.
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considers your comment on this draft
guidance before it begins work on the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
either electronic or written comments
on the draft guidance by June 9, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Nutrition, Labeling, and
Dietary Supplements (HFS–820), Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
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draft guidance to https://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.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
April Kates, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2371.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Proper Labeling of Honey and Honey
Products’’ dated February 2014. On
March 8, 2006, the American
Beekeeping Federation and several other
honey-related associations submitted a
citizen petition requesting that FDA
adopt a U.S. standard of identity for
honey based on the 2001 Revised Codex
Alimentarius Commission’s Standard
for Honey. The petitioners asserted that
a U.S. standard of identity for honey
would achieve the following goals: (1)
Clarify what the term ‘‘honey’’ means
with respect to the food’s composition
and therefore promote honesty and fair
dealing in the interest of consumers; (2)
combat economic adulteration of honey
by aiding enforcement and industry
compliance; and (3) promote honesty
and fair dealing within the food trade in
general, where pure honey is used as an
ingredient in other food. In a letter
dated October 5, 2011, we denied the
petition because the petition did not
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17:54 Apr 08, 2014
Jkt 232001
provide reasonable grounds for FDA to
adopt the Codex standard for honey. We
also concluded that the petitioners’
goals can be achieved by FDA’s existing
authorities and that a standard of
identity for honey would not promote
honesty and fair dealing in the interest
of consumers.
To address the labeling issues
relevant to the petition, we developed
this draft guidance to advise the
regulated food industry on the proper
labeling of honey and honey products to
help ensure that honey and honey
products are not adulterated or
misbranded under sections 402 and 403
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342 and 343,
respectively).
We are issuing this draft guidance
document consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent FDA’s current
thinking on the labeling of honey and
honey products. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternate approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 collections
of information in 21 CFR 101.4, 101.22,
and 102 have been approved under
OMB control number 0910–0381.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance document
at https://www.fda.gov/FoodGuidances
or https://www.regulations.gov.
PO 00000
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19621
Dated: April 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07925 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–2014–D–0310]
Draft Guidance for Industry on
Immunogenicity-Related
Considerations for the Approval of
Low Molecular Weight Heparin for New
Drug Applications and Abbreviated
New Drug Applications; 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 ‘‘ImmunogenicityRelated Considerations for the Approval
of Low Molecular Weight Heparin for
NDAs and ANDAs.’’ This guidance
discusses how applicants for low
molecular weight heparin (LMWH)
products should provide information on
impurities and the potential impact on
immunogenicity.
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
either electronic or written comments
on the draft guidance by June 9, 2014.
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 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
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.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Daniela Verthelyi, Center for Drug
Evaluation and Research (HFD–122),
Food and Drug Administration, 9000
Rockville Pike, N29A, Rm. 3B19,
Bethesda, MD 20892, 301–827–1702.
SUMMARY:
E:\FR\FM\09APN1.SGM
09APN1
19622
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.
VerDate Mar<15>2010
17:54 Apr 08, 2014
Jkt 232001
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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]
[Pages 19621-19622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07896]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0310]
Draft Guidance for Industry on Immunogenicity-Related
Considerations for the Approval of Low Molecular Weight Heparin for New
Drug Applications and Abbreviated New Drug Applications; 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
``Immunogenicity-Related Considerations for the Approval of Low
Molecular Weight Heparin for NDAs and ANDAs.'' This guidance discusses
how applicants for low molecular weight heparin (LMWH) products should
provide information on impurities and the potential impact on
immunogenicity.
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 either electronic or written comments on the draft
guidance by June 9, 2014.
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 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
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. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Daniela Verthelyi, Center for Drug
Evaluation and Research (HFD-122), Food and Drug Administration, 9000
Rockville Pike, N29A, Rm. 3B19, Bethesda, MD 20892, 301-827-1702.
[[Page 19622]]
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.
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.
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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
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