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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
You may submit comments on any guidance at any time as follows:

ADDRESSES:

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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 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
2021D1139 for IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or LifeThreatening Diseases: Chemistry, Manufacturing, and Controls Recommendations. 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
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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.
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:

Carla R. Lankford, Center for Drug Evaluation and Research HFD123, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
6656, Silver Spring, MD 209930002, 3017965203.
SUPPLEMENTARY INFORMATION:

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I. Background FDA is announcing the availability of a draft guidance for industry entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations. The purpose of this draft guidance is to provide FDAs current thinking on the recommended CMC data and information to support an IND submitted by a sponsor-investigator developing an ASO drug product for a small number of individuals typically one or two with an SDLT disease. This draft guidance also explains FDAs recommendations around compliance with current good manufacturing practice, including the applicability of 21 CFR part 211, to support investigational use of an ASO drug product in a small number of individuals with an SDLT disease.
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 IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations. 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. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR parts 312 and 314 have been approved under OMB
control numbers 09100014 and 0910
0001, respectively. The collections of information in 21 CFR 211 for manufacture of drug product is approved under OMB control number 09100139. The collections of information for oversight of clinical investigations and safety reporting have been approved under OMB control number 09100733.

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