Guidance for Industry on Immunogenicity-Related Considerations for Low Molecular Weight Heparin; Availability, 8501-8502 [2016-03461]

Download as PDF 8501 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices application for NEW program funding. As approved by the Department of Health and Human Services (HHS), it documents how the grantee will carry out its NEW program. The NEW program plan guidance provides instructions for preparing a NEW program plan and explains the process for plan submission every third year. There are two versions of this plan guidance: One for tribes that include their NEW program in a Public Law 102–477 project, and one for tribes that do not. The primary difference between the guidance documents is in the instructions for how to submit the plan. The NEW program report provides information on the activities and accomplishments of grantees’ NEW programs. The NEW program report and instructions specify the program data that NEW grantees report annually. Respondents: Federally recognized Indian Tribes and Tribal organizations that are NEW program grantees. 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Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–03460 Filed 2–18–16; 8:45 am] asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4184–01–P 17:59 Feb 18, 2016 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Immunogenicity-Related Considerations for Low Molecular Weight Heparin.’’ This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and their potential impact on immunogenicity. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: SUMMARY: OMB Comment VerDate Sep<11>2014 Guidance for Industry on Immunogenicity-Related Considerations for Low Molecular Weight Heparin; Availability ACTION: Jkt 238001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 1 1 1 2 11 Estimated Total Annual Burden Hours: 1,414. AGENCY: Number of responses per respondent Average burden hours per response 29 29 15 Total burden hours 435 319 660 anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–D–0310 for ‘‘ImmunogenicityRelated Considerations for Low Molecular Weight Heparin.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper E:\FR\FM\19FEN1.SGM 19FEN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 8502 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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. FOR FURTHER INFORMATION CONTACT: Daniela Verthelyi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240–402–7450. SUPPLEMENTARY INFORMATION: Weight Heparin.’’ It finalizes the draft guidance entitled ‘‘ImmunogenicityRelated Considerations for the Approval of Low Molecular Weight Heparin for New Drug Applications and Abbreviated New Drug Applications’’ that published on April 9, 2014 (79 FR 19621). FDA has considered the comments submitted to the public docket and modified statements and added terms for clarity. This 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. This guidance also includes recommendations for ANDA applicants on meeting the requirement for active ingredient sameness, because a demonstration of active ingredient sameness helps to address immunogenicity considerations in this context. In addition, this guidance discusses how to address changes in the source material or other component, or when there are modifications to the manufacturing process after completion of supporting clinical studies, either before or after approval of the application. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the Agency’s current thinking on immunogenicity considerations for low molecular weight heparin. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. I. Background Dated: February 16, 2016. Leslie Kux, Associate Commissioner for Policy. FDA is announcing the availability of a guidance for industry entitled ‘‘Immunogenicity-Related Considerations for Low Molecular VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 II. The Paperwork Reduction Act 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. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. [FR Doc. 2016–03461 Filed 2–18–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0584] Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. This notice announces a forthcoming meeting of public advisory committees of the Food and Drug Administration (FDA). The meeting will be open to the public. Names of Committees: Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 15, 2016, from 8 a.m. to 5 p.m. and September 16, 2016, from 8 a.m. to 5 p.m. Addresses: FDA is opening a docket for public comment on this meeting. The docket number is FDA–2016–N– 0584. The docket will open for public comment on February 19, 2016. The docket will close on September 30, 2016. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments 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. All comments received will be posted without change, including any personal information provided. 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. Comments received on or before August 31, 2016, will be provided to the committee before the meeting. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Answers to commonly asked questions including information regarding special accommodations due E:\FR\FM\19FEN1.SGM 19FEN1

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[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8501-8502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0310]


Guidance for Industry on Immunogenicity-Related Considerations 
for Low Molecular Weight Heparin; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Immunogenicity-
Related Considerations for Low Molecular Weight Heparin.'' This 
guidance discusses how applicants for low molecular weight heparin 
(LMWH) products should provide information on impurities and their 
potential impact on immunogenicity.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-0310 for ``Immunogenicity-Related Considerations for Low 
Molecular Weight Heparin.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper

[[Page 8502]]

submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Daniela Verthelyi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 240-402-7450.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Immunogenicity-Related Considerations for Low Molecular 
Weight Heparin.'' It finalizes the draft guidance entitled 
``Immunogenicity-Related Considerations for the Approval of Low 
Molecular Weight Heparin for New Drug Applications and Abbreviated New 
Drug Applications'' that published on April 9, 2014 (79 FR 19621). FDA 
has considered the comments submitted to the public docket and modified 
statements and added terms for clarity.
    This 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. This guidance also includes recommendations for ANDA applicants 
on meeting the requirement for active ingredient sameness, because a 
demonstration of active ingredient sameness helps to address 
immunogenicity considerations in this context. In addition, this 
guidance discusses how to address changes in the source material or 
other component, or when there are modifications to the manufacturing 
process after completion of supporting clinical studies, either before 
or after approval of the application.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
Agency's current thinking on immunogenicity considerations for low 
molecular weight heparin. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act

    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. Electronic Access

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

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03461 Filed 2-18-16; 8:45 am]
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