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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices
date. Please note that late, untimely comments will not be considered.
Electronic comments must be submitted on or before September 24, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 24, 2021. 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.
You may submit comments as follows:

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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
2021N0834 for Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public
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Docket; Request for Comments.
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. FDA
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 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 the 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, September18, 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.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 2404023838, marieann.brill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary
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drugs, biological products, medical devices, our Nations food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is establishing a public docket, Docket No. FDA2021N0834, to receive input on post-marketing pediatric-focused safety reviews of products posted between September 2, 2020, and September 2, 2021, available on FDAs website at https
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm but not presented at the September 17, 2021, PAC meeting. FDA
welcomes comments by members of the PAC, as mandated by the Best Pharmaceuticals for Children Act Pub.
L. 107109 and the Pediatric Research Equity Act of 2003 Pub. L. 108155, interested parties such as academic researchers, regulated industries, consortia, and patient groups, and the general public. The docket number is FDA2021N0834. The docket will open on September 3, 2021, and remain open until September 24, 2021. The post-marketing pediatric-focused safety reviews are for the following products from the following centers at FDA:
Center for Biologics Evaluation and Research 1. CUVITRU immune globulin subcutaneous human, 20 percent solution 2. EPICEL cultured epidermal autografts 3. JIVI antihemophilic factor recombinant, PEGylated-aucl 4. T.R.U.E. TEST thin-layer rapid use epicutaneous patch test 5. REBINYN nonacog beta pegol N9
GP
6. RUBBER PANEL T.R.U.E. TEST
Rubber Panel thin-layer rapid use epicutaneous patch test 7. ROTATEQ Rotavirus vaccine, live, oral, pentavalent Center for Drug Evaluation and Research 1. APTIOM eslicarbazepine acetate 2. CIALIS tadalafil 3. COTEMPLA XRODT
methylphenidate extended release orally disintegrating tablets 4. EMEND fosaprepitant dimeglumine 5. ENBREL etanercept, ERELZI
etanercept-szzs, ETICOVO
etanercept-ykro 6. FASENRA benralizumab 7. INTELENCE etravirine 8. PEGASYS peginterferon alfa-2a
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