Document ID: FDA-2014-D-0310-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Immunogenicity-Related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
Posted Date: 2014-04-09T04:00Z

[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Draft Guidance for Industry on Immunogenicity-Related 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.

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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availability of a draft guidance for industry entitled 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 9, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 http://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 http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07896 Filed 4-8-14; 8:45 am]
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