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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES

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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Brian Booth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993, 3017961508.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death
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Receptor-1 PD1 or Programmed Cell Death-Ligand 1 PDL1 Blocking Antibodies for Treatment of Patients with Cancer. This draft guidance provides recommendations for sponsors of INDs and BLAs on the use of PKbased criteria to support the approval of alternative dosing regimens for PD1 or PDL1 blocking antibodies. The draft guidance is based on accumulated scientific and regulatory experience for PD1 and PDL1 drugs and, as such, does not address development of alternative dosing regimens for any other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD1/PDL1 products.
Sponsors may seek approval of alternative intravenous IV dosing regimens that are different from those tested in clinical efficacy and safety trials. These alternative IV dosing regimens are typically designed to change doses e.g., body weight adjusted doses to flat doses and/or dosing intervals e.g., once every 3 weeks to once every 6 weeks. Longer dosing interval periods can minimize patient burden and reduce risks associated with more frequent administration e.g., infusion reactions, as well as exposure to communicable diseases e.g., SARS
CoV2 associated with visits to hospitals or infusion centers. The draft guidance describes the criteria for using the PK-based approach and the documents that should be included in the submissions seeking approval.
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 Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 PD1 or Programmed Cell Death-Ligand 1 PDL1 Blocking Antibodies for Treatment of Patients with Cancer. 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
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information in 21 CFR part 312 have been approved under OMB control number 09100014 and the collections of information in 21 CFR part 601 have been approved under 09100338.
III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https
www.regulations.gov.
Dated: August 17, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Meeting of the Advisory Committee on Infant Mortality Health Resources and Services Administration HRSA, Department of Health and Human Services.
ACTION: Notice.
AGENCY:

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant Mortality ACIM or Committee has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https
www.hrsa.gov/advisory-committees/
infant-mortality/index.html.
DATES: September 21, 2021, 12:00 p.m.
4:00 p.m. Eastern Time and September 22, 2021, 12:00 p.m.4:00 p.m. Eastern Time.
ADDRESSES: This meeting will be held via webinar. The webinar link and login information will be available at ACIMs website before the meeting:
https www.hrsa.gov/advisorycommittees/infant-mortality/index.html.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal Official, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room 18N84, Rockville, Maryland 20857; 301 4430543; or SACIM@
hrsa.gov.
SUMMARY:

ACIM is authorized by section 222 of the Public Health Service Act 42 U.S.C. 217a, as amended. The Committee is governed
SUPPLEMENTARY INFORMATION:

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