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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES

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
2018D1216 for Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date. 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

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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:
Jonathan Resnick, Center for Drug Evaluation and Research CDER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 209930002, 301
7967997, Jonathan.Resnick@
fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993
0002, 2404027911, Stephen.Ripley@
fda.hhs.gov.
In accordance with the guidance 1 for industry Providing Regulatory Submissions in Electronic Format Standardized Study Data, submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless they have an exemption or waiver from the electronic submission requirements. The Agency can process, review, and archive electronic submissions of study data that use the standards specified in the Data Standards Catalog posted to FDAs Study Data Standards Resources web page https www.fda.gov/industry/fdaresources-data-standards/study-datastandards-resources.
The technical rejection criteria are automated validations by the CDER or CBER inbound processing system using the specifications set forth in FDAs Specifications for eCTD Validation Criteria to determine compliance with the requirement to submit electronic standardized study data. The eCTD
validations referenced in FDAs TRC
will become effective on September 15, 2021. Starting September 15, 2021, FDA
will reject submissions that contain any high validation errors included in the TRC. The latest version of the TRC is available on FDAs web page on Study Data for Submission to CDER and CBER
https www.fda.gov/industry/studydata-standards-resources/study-datasubmission-cder-and-cber.

SUPPLEMENTARY INFORMATION:

1 Under section 745Aa of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C.
379k1a, at least 24 months after the issuance of a final guidance document in which FDA has specified the electronic format for submitting certain submission types to the Agency, such content must be submitted electronically and in the format specified by FDA.

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Dated: July 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116187 Filed 72821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2012N0547

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.

SUMMARY:

Submit written comments including recommendations on the collection of information by August 30, 2021.

DATES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100744. Also include the FDA docket number found in brackets in the heading of this document.

ADDRESSES:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

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