81 FR 8501 - Guidance for Industry on Immunogenicity-Related Considerations for Low Molecular Weight Heparin; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 33 (February 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 33 (February 19, 2016)
| Page Range | 8501-8502 | |
| FR Document | 2016-03461 |
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)] [Notices] [Pages 8501-8502] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03461] ----------------------------------------------------------------------- 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] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8501
application for NEW program funding. There are two versions of this plan accomplishments of grantees’ NEW
As approved by the Department of guidance: One for tribes that include programs. The NEW program report and
Health and Human Services (HHS), it their NEW program in a Public Law instructions specify the program data
documents how the grantee will carry 102–477 project, and one for tribes that that NEW grantees report annually.
out its NEW program. The NEW do not. The primary difference between Respondents: Federally recognized
program plan guidance provides the guidance documents is in the
Indian Tribes and Tribal organizations
instructions for preparing a NEW instructions for how to submit the plan.
that are NEW program grantees.
program plan and explains the process The NEW program report provides
for plan submission every third year. information on the activities and
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
NEW program plan guidance for non-477 Tribes ........................................... 1 15 1 29 435
NEW program plan guidance for 477 Tribes ................................................... 2 11 1 29 319
NEW program report ....................................................................................... 3 44 1 15 660
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Hours: 1,414. HUMAN SERVICES confidential business information, such
as a manufacturing process. Please note
Additional Information Food and Drug Administration that if you include your name, contact
Copies of the proposed collection may information, or other information that
[Docket No. FDA–2014–D–0310]
be obtained by writing to the identifies you in the body of your
Guidance for Industry on comments, that information will be
Administration for Children and
Immunogenicity-Related posted on http://www.regulations.gov.
Families, Office of Planning, Research • If you want to submit a comment
and Evaluation, 330 C Street SW., Considerations for Low Molecular
Weight Heparin; Availability with confidential information that you
Washington, DC 20201. Attention do not wish to be made available to the
Reports Clearance Officer. All requests AGENCY: Food and Drug Administration, public, submit the comment as a
should be identified by the title of the HHS. written/paper submission and in the
information collection. Email address: ACTION: Notice. manner detailed (see ‘‘Written/Paper
infocollection@acf.hhs.gov. Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
OMB Comment Written/Paper Submissions
Administration (FDA) is announcing the
OMB is required to make a decision availability of a guidance for industry Submit written/paper submissions as
entitled ‘‘Immunogenicity-Related follows:
concerning the collection of information
Considerations for Low Molecular • Mail/Hand delivery/Courier (for
between 30 and 60 days after written/paper submissions): Division of
publication of this document in the Weight Heparin.’’ This guidance
discusses how applicants for low Dockets Management (HFA–305), Food
Federal Register. Therefore, a comment and Drug Administration, 5630 Fishers
is best assured of having its full effect molecular weight heparin (LMWH)
products should provide information on Lane, Rm. 1061, Rockville, MD 20852.
if OMB receives it within 30 days of
impurities and their potential impact on • For written/paper comments
publication. Written comments and submitted to the Division of Dockets
immunogenicity.
recommendations for the proposed Management, FDA will post your
DATES: Submit either electronic or comment, as well as any attachments,
information collection should be sent
directly to the following: Office of written comments on Agency guidances except for information submitted,
at any time. marked and identified, as confidential,
Management and Budget, Paperwork
Reduction Project, Email: OIRA_ ADDRESSES: You may submit comments if submitted as detailed in
SUBMISSION@OMB.EOP.GOV, Attn: as follows: ‘‘Instructions.’’
Desk Officer for the Administration for Instructions: All submissions received
Electronic Submissions
Children and Families. must include the Docket No. FDA–
Submit electronic comments in the 2014–D–0310 for ‘‘Immunogenicity-
Robert Sargis, following way: Related Considerations for Low
Reports Clearance Officer. • Federal eRulemaking Portal: http:// Molecular Weight Heparin.’’ Received
[FR Doc. 2016–03460 Filed 2–18–16; 8:45 am]
www.regulations.gov. Follow the comments will be placed in the docket
instructions for submitting comments. and, except for those submitted as
BILLING CODE 4184–01–P
Comments submitted electronically, ‘‘Confidential Submissions,’’ publicly
including attachments, to http:// viewable at http://www.regulations.gov
asabaliauskas on DSK5VPTVN1PROD with NOTICES
www.regulations.gov will be posted to or at the Division of Dockets
the docket unchanged. Because your Management between 9 a.m. and 4 p.m.,
comment will be made public, you are Monday through Friday.
solely responsible for ensuring that your • Confidential Submissions—To
comment does not include any submit a comment with confidential
confidential information that you or a information that you do not wish to be
third party may not wish to be posted, made publicly available, submit your
such as medical information, your or comments only as a written/paper
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![8502 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
submission. You should submit two Weight Heparin.’’ It finalizes the draft DEPARTMENT OF HEALTH AND
copies total. One copy will include the guidance entitled ‘‘Immunogenicity- HUMAN SERVICES
information you claim to be confidential Related Considerations for the Approval
with a heading or cover note that states of Low Molecular Weight Heparin for Food and Drug Administration
‘‘THIS DOCUMENT CONTAINS New Drug Applications and [Docket No. FDA–2016–N–0584]
CONFIDENTIAL INFORMATION’’. The Abbreviated New Drug Applications’’
Agency will review this copy, including that published on April 9, 2014 (79 FR Anesthetic and Analgesic Drug
the claimed confidential information, in 19621). FDA has considered the Products Advisory Committee, the
its consideration of comments. The comments submitted to the public Drug Safety and Risk Management
second copy, which will have the docket and modified statements and Advisory Committee, and the Pediatric
claimed confidential information added terms for clarity. Advisory Committee; Notice of Meeting
redacted/blacked out, will be available This guidance provides
for public viewing and posted on http:// recommendations to applicants for new AGENCY: Food and Drug Administration,
www.regulations.gov. Submit both drug applications (NDAs) and HHS.
copies to the Division of Dockets abbreviated new drug applications ACTION: Notice; request for comments.
Management. If you do not wish your (ANDAs) regarding impurities and their
potential effect on immunogenicity for This notice announces a forthcoming
name and contact information to be
LMWH. This guidance also includes meeting of public advisory committees
made publicly available, you can
recommendations for ANDA applicants of the Food and Drug Administration
provide this information on the cover
on meeting the requirement for active (FDA). The meeting will be open to the
sheet and not in the body of your
ingredient sameness, because a public.
comments and you must identify this Names of Committees: Anesthetic and
information as ‘‘confidential.’’ Any demonstration of active ingredient
Analgesic Drug Products Advisory
information marked as ‘‘confidential’’ sameness helps to address
Committee, the Drug Safety and Risk
will not be disclosed except in immunogenicity considerations in this
Management Advisory Committee, and
accordance with 21 CFR 10.20 and other context. In addition, this guidance
the Pediatric Advisory Committee.
applicable disclosure law. For more discusses how to address changes in the
General Function of the Committees:
information about FDA’s posting of source material or other component, or
To provide advice and
comments to public dockets, see 80 FR when there are modifications to the
recommendations to the Agency on
56469, September 18, 2015, or access manufacturing process after completion
FDA’s regulatory issues.
the information at: http://www.fda.gov/ of supporting clinical studies, either Date and Time: The meeting will be
regulatoryinformation/dockets/ before or after approval of the held on September 15, 2016, from 8 a.m.
default.htm. application. to 5 p.m. and September 16, 2016, from
Docket: For access to the docket to This guidance is being issued
8 a.m. to 5 p.m.
read background documents or the consistent with FDA’s good guidance Addresses: FDA is opening a docket
electronic and written/paper comments practices regulation (21 CFR 10.115). for public comment on this meeting.
received, go to http:// This guidance represents the Agency’s The docket number is FDA–2016–N–
www.regulations.gov and insert the current thinking on immunogenicity 0584. The docket will open for public
docket number, found in brackets in the considerations for low molecular weight comment on February 19, 2016. The
heading of this document, into the heparin. It does not establish any rights docket will close on September 30,
‘‘Search’’ box and follow the prompts for any person and is not binding on 2016. Interested persons may submit
and/or go to the Division of Dockets FDA or the public. You can use an either electronic or written comments
Management, 5630 Fishers Lane, Rm. alternative approach if it satisfies the regarding this meeting. Submit
1061, Rockville, MD 20852. requirements of the applicable statutes electronic comments to http://
Submit written requests for single and regulations. www.regulations.gov. Submit written
copies of this guidance to the Division II. The Paperwork Reduction Act comments to the Division of Dockets
of Drug Information, Center for Drug Management (HFA–305), Food and Drug
Evaluation and Research, Food and This guidance refers to a previously
approved collection of information that Administration, 5630 Fishers Lane, Rm.
Drug Administration, 10001 New 1061, Rockville, MD 20852. All
Hampshire Ave., Hillandale Building, is subject to review by the Office of
Management and Budget (OMB) under comments received will be posted
4th Floor, Silver Spring, MD 20993– without change, including any personal
0002. Send one self-addressed adhesive the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of information provided. It is only
label to assist that office in processing necessary to send one set of comments.
your requests. See the SUPPLEMENTARY information in 21 CFR part 314 has been
approved under OMB control number Identify comments with the docket
INFORMATION section for electronic number found in brackets in the
access to the guidance document. 0910–0001.
heading of this document. Received
FOR FURTHER INFORMATION CONTACT: III. Electronic Access comments may be seen in the Division
Daniela Verthelyi, Center for Drug Persons with access to the Internet of Dockets Management between 9 a.m.
Evaluation and Research, Food and may obtain the guidance at either http:// and 4 p.m., Monday through Friday.
Drug Administration, 10903 New www.fda.gov/Drugs/Guidance Comments received on or before August
Hampshire Ave., Silver Spring, MD 31, 2016, will be provided to the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ComplianceRegulatoryInformation/
20993, 240–402–7450. Guidances/default.htm or http:// committee before the meeting.
SUPPLEMENTARY INFORMATION: www.regulations.gov. Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
I. Background Dated: February 16, 2016. 31 Conference Center, the Great Room
FDA is announcing the availability of Leslie Kux, (Rm. 1503), Silver Spring, MD 20993–
a guidance for industry entitled Associate Commissioner for Policy. 0002. Answers to commonly asked
‘‘Immunogenicity-Related [FR Doc. 2016–03461 Filed 2–18–16; 8:45 am] questions including information
Considerations for Low Molecular BILLING CODE 4164–01–P regarding special accommodations due
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Document Created: 2018-02-02 14:31:45
Document Modified: 2018-02-02 14:31:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Daniela Verthelyi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-7450. | |
| FR Citation | 81 FR 8501 |
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