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lotter on DSK11XQN23PROD with NOTICES1

Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 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 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, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 209930002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3334, Silver Spring, MD 209930002, 2404028926; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 209930002, 240
4027911.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a guidance for industry entitled
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Providing Regulatory Submissions in Alternate Electronic Format. This guidance provides recommendations on an alternate electronic format for submissions that are covered under an exemption from or granted a waiver of the requirements of section 745Aa of the FD&C Act 21 U.S.C. 379k1. These recommendations pertain to the electronic format of content in NDAs, ANDAs, certain DMFs, certain BLAs, and certain INDs submitted to the Center for Drug Evaluation and Research or to the Center for Biologics Evaluation and Research.
This guidance includes information on: 1 How to submit in alternate electronic format without XML
backbone, 2 submission of FDA forms, 3 pre-submission considerations, 4
submission structure, 5 file formats and versions, 6 datasets and study information, 7 transmitting electronic submissions, and 8 receipt dates.
This guidance finalizes the draft guidance of the same title issued on March 11, 2020 85 FR 14202. FDA
considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to final guidance include: 1 Minor edits to clarify recommendations for the location of the Table of Contents for the alternate electronic format, 2 an example of the folder structure, and 3
the process for submission if an electronic signature is not possible. In addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
This final guidance represents FDAs current thinking on Providing Regulatory Submissions in Alternate Electronic Format. 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 part 312 have been approved under OMB control number 09100014; the collections of information in 21 CFR part 314 have been approved under OMB control
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number 09100001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 09100338.
III. Electronic Access Persons with access to the internet may obtain the guidance at https
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https
www.regulations.gov.
Dated: June 28, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0008

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. The meeting will be open to the public.
DATES: The meeting will take place virtually on August 3, 2021, from 9 a.m.
Eastern Time to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at: https
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm. 5214, Silver Spring, MD 209930002, SUMMARY:

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