Draft Guidance for Industry on Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for New Drug Applications and Abbreviated New Drug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]

Download as PDF 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 FDA developed this draft guidance to advise firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 9, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS–820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov.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 SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Proper Labeling of Honey and Honey Products’’ dated February 2014.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 VerDate Mar<15>2010 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 Frm 00046 Fmt 4703 Sfmt 4703 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]


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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
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