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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations TABLE 3ESTIMATED ANNUAL REPORTING BURDEN 1Continued 21 CFR Section; activity Total

Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response

Total hours 215

1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
2 A Codex MRL is a permanent maximum residue limit MRL that has been established by the Codex Alimentarius Committee.

We base our estimate of the number of respondents and number of responses per respondent in table 3 on our experience since the passage of the ADAA and the number of actual requests received. We base our estimate of the average burden per response on our experience with the human food safety technical section of an NADA, as discussed previously in this document.
A request to establish or amend an import tolerance must include human food safety data and other information.
The information submitted is similar to that submitted to establish a tolerance under an NADA. The collection of information required for submission of NADAs has been reviewed under the PRA. A proportion of the time estimated in that proposed extension for the paperwork associated with the human food safety technical section of an NADA was used to estimate the time hours per response presented in table 3 for the preparation of a request to establish or amend an import tolerance not based on a permanent Codex MRL, approximately 80 hours. We believe a request to establish or amend an import tolerance based on a permanent Codex MRL will be less burdensome, approximately 50 hours. Based on the Agencys experience with establishing tolerances for approved new animal drugs, the Agency believes that requests to revoke an import tolerance, as well as petitions for reconsideration of an action or for an administrative stay of an action, will be infrequent occurrences.
If there is a permanent Codex MRL for a new animal drug, the final rule requires the requester to provide the permanent Codex MRL and monographs and reports from the Joint FAO/World Health Organization of the United Nations WHO Expert Committee on Food Additives JECFA and/or the Joint FAO/WHO Meeting on Pesticide Residues JMPR that support the development of the Codex MRL.
If there is not a permanent Codex MRL, or upon notification by FDA, the final rule requires the requester to provide full reports of investigations made with respect to the human food safety of the new animal drug including data submitted to the appropriate regulatory authority in any country in
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which the new animal drug is lawfully used. We may regard a request as incomplete unless it includes full reports of adequate tests by all methods reasonably applicable to show whether or not food derived from animals receiving the new animal drug will be safe for human consumption.
The information collection provisions of this final rule have been submitted to OMB for review as required by section 3507d of the PRA. Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMBs decision to approve, modify, or disapprove the information collection provisions in this final rule.
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
X. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the
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Executive Order and, consequently, a tribal summary impact statement is not required.
List of Subjects 21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 20
Confidential business information, Courts, Freedom of information, Government employees.
21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements.
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and containers, Polychlorinated biphenyls PCBs.
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 10, 20, 25, 500, and 510 are amended as follows:
PART 10ADMINISTRATIVE
PRACTICES AND PROCEDURES
1. The authority citation for part 10
continues to read as follows:

Authority: 5 U.S.C. 551558, 701706; 15
U.S.C. 14511461; 21 U.S.C. 141149, 321
397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

2. In 10.25, revise paragraph a1 to read as follows:

10.25 Initiation of administrative proceedings.

a
1 In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in 71.1, for a food additive petition in 171.1 or 571.1, for a new drug application in 314.50, for a request to establish or amend an import tolerance
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