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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
Public Law 92463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel SEP
RFAOH22003, Occupational Safety and Health Training Project Grants.
Date: February 12, 2022.
Time: 1:00 p.m.4:00 p.m., EST.
Place: Video-Assisted Meeting.
Agenda: To review and evaluate grant applications.
For Further Information Contact:
Marilyn Ridenour, B.S.N., M.P.H., Scientific Review Officer, Office of Extramural Programs, National Institute for Occupational Safety and Health, CDC, 1095 Willowdale Road, Morgantown, West Virginia 26505, Telephone: 304 2855879; Email:
MRidenour@cdc.gov.
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Notice of availability.

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.

The Food and Drug Administration FDA or Agency is announcing the availability of a draft
Written/Paper Submissions Submit written/paper submissions as follows:

Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.
FR Doc. 202126575 Filed 12721; 8:45 am BILLING CODE 416318P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D1140

jspears on DSK121TN23PROD with NOTICES1

guidance for sponsor-investigators entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or LifeThreatening Diseases: Clinical Recommendations. FDA is publishing this draft guidance to provide sponsorinvestigators hereafter referred to as sponsors who are interested in developing individualized antisense oligonucleotide ASO drug products for a rapidly progressive, severely debilitating, or life-threatening SDLT
genetic disease caused by a unique genetic variant or variants, with clinical recommendations for submission of investigational new drug applications INDs. These recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment.
DATES: Submit either electronic or written comments on the draft guidance by February 7, 2022 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:

Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations; Draft Guidance for Sponsor-Investigators; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

SUMMARY:

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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
2021D1140 for IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or LifeThreatening Diseases: Clinical 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 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
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