Quiero saber acerca de...

36560

Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.

khammond on DSKJM1Z7X2PROD 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
2019D1997 for FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff. 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.

VerDate Sep<11>2014

17:26 Jul 09, 2021

Jkt 253001

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 a single hard copy of the draft guidance entitled FDA Oversight of Food Products Covered by Systems Recognition Arrangements to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rm. 4148, Rockville, MD 20857. 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.

II. Paperwork Reduction Act of 1995

FOR FURTHER INFORMATION CONTACT:

Docket No. FDA2019D5364

Marla Hallacy, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, 2404026674.

Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised; Guidance for Industry; Availability
SUPPLEMENTARY INFORMATION:

AGENCY:

I. Background
HHS.

FDA is announcing the availability of a draft guidance for FDA staff entitled FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA
Staff. The draft guidance is part of FDAs larger effort to take a risk-based approach to food safety to include ensuring the safety of imported food, consistent with the FDA Food Safety Modernization Act. The guidance covers FDAs regulatory oversight activities for food products covered by SRAs between FDA and its foreign regulatory counterparts. Currently, the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.
The 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 the topic of Systems Recognition Arrangement implementation. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

PO 00000

Frm 00039

Fmt 4703

Sfmt 4703

FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https
www.regulations.gov.
Dated: July 6, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202114789 Filed 7921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:

Food and Drug Administration,
Notice of availability.

The Food and Drug Administration FDA or Agency is announcing the availability of a revised final guidance for industry entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements Revised. This is a revision to the third edition of this final guidance, which issued in February 2021, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled Tobacco Products; Required Warnings for Cigarette Packages and Advertisements to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.

SUMMARY:

E:FRFM12JYN1.SGM

12JYN1