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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices ANNUAL BURDEN ESTIMATES
Instrument
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4,480

ACF901: American Rescue Plan ARP Stabilization Grants Provider-Level Data

Authority: The Child Care and Development Block Grant Act 42 U.S.C.
9857 et seq.; 45 CFR parts 98 and 99;
the ARP Act of 2021 Sec. 2202, Pub. L.
1172.
Mary B. Jones, ACF/OPRE Certifying Officer.
FR Doc. 202123683 Filed 102921; 8:45 am BILLING CODE 418484P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2017E5720; FDA
2017E5724; FDA2017E5740; and FDA
2017E5748

Determination of Regulatory Review Period for Purposes of Patent Extension; SPINRAZA
AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SPINRAZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office USPTO, Department of Commerce, for the extension of patents which claims that human drug product.
DATES: Anyone with knowledge that any of the dates as published the SUPPLEMENTARY INFORMATION are incorrect may submit either electronic or written comments and ask for a redetermination by January 3, 2022.
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 2, 2022. See Petitions in the SUPPLEMENTARY INFORMATION section for more information.
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must
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be submitted on or before January 3, 2022. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2022. Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
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.

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Instructions: All submissions received must include the Docket Nos. FDA
2017E5720; FDA2017E5724;
FDA2017E5740; and FDA2017E
5748 for Determination of Regulatory Review Period for Purposes of Patent Extension; SPINRAZA. Received comments, those filed in a timely manner see ADDRESSES, 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 10.20 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
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