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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
The Food and Drug Administration FDA or Agency is announcing the availability of a draft guidance for industry entitled Rabies:
Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis. The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody mAb cocktails as an alternative to anti-rabies virus immunoglobulin RIG as the passive immunization component of postexposure prophylaxis PEP for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal.
DATES: Submit either electronic or written comments on the draft guidance by September 27, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as follows:
SUMMARY:

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Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https
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 elses 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 https 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: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management
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Staff, 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
2021D0519 for Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis. Received comments will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper 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 https www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.

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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, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Stephanie Troy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6381, Silver Spring, MD 209930002, 240
4024656.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of PostExposure Prophylaxis. The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus mAb cocktails as an alternative to RIG
as the passive immunization component of PEP for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. Because of the unique complexities of drug development in this area, extensive discussion with multiple stakeholders has taken place, including a public workshop in 2017 and an advisory committee meeting in 2019. These discussions helped FDA formulate the considerations for rabies mAb cocktail development that are described in this draft guidance.
The draft guidance addresses the following topics:
Considerations when selecting the mAbs included in the cocktail The nonclinical and clinical data needed to support clinical trials of the mAb cocktail in potentially rabies virusexposed subjects The clinical data recommended to support an initial biologics license application submission of the mAb cocktail for a second-line indication in situations where human-derived RIG is not available The clinical data recommended to support a first-line indication for the mAb cocktail This draft guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The draft guidance, when finalized, will represent the current thinking of FDA
on Rabies: Developing Monoclonal
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