Federal Register - September 3, 2021
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Source: Federal Register
49546
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices TABLE 4ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1
21 CFR section; activity
Number of respondents
Number of disclosures per respondent
Total annual disclosures
Average burden per disclosure
Total hours
37,134
1
37,134
0.25 15 minutes
9,284
117.201e; disclosure of food manufacturing facility address.
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 5ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: ANIMAL FOOD 1
Number of respondents
21 CFR section; activity 507.27b; labeling for the animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species.
507.7e1; change labels on products with labels.
507.7e2; change address on labeling sales documents for qualified facilities.
507.25a2; animal food, including raw materials, other ingredients, and rework, is accurately identified.
507.28b; holding and distribution of human food byproducts for use as animal food.
Total
1 There
Average burden per disclosure
Total hours
10
3,300
0.25 15 minutes
825
1,120
4
4,480
1
4,480
974
1
974
1
974
373
312
116,376
0.01 36 seconds
1,163.76
40,798
2
81,596
0.25 15 minutes
20,399
27,841.76
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119116 Filed 9221; 8:45 am BILLING CODE 416401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1
Total annual disclosures
330
Based on a review of the information collection since our last request for OMB approval, we have made slight adjustments to reflect a decrease in third-party disclosure burden associated with animal food. In this submission we provide a cumulative estimate for related disclosure activities that we had previously accounted for separately.
Docket No. FDA2021N0897
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:
Number of disclosures per respondent
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:55 Sep 02, 2021
Jkt 253001
Notice; establishment of a public docket; request for comments.
ACTION:
The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
DATES: The meeting will be held on October 28, 2021, from 10:30 a.m. to 3
p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA2021N0897.
SUMMARY:
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The docket will close on October 27, 2021. Submit either electronic or written comments on this public meeting by October 27, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2021. The https
www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 27, 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.
Comments received on or before October 14, 2021, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
E:FRFM03SEN1.SGM
03SEN1