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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule.
The full analysis of economic impacts is available in the docket for this final rule FDA2001N0075 and at https
www.fda.gov/about-fda/reports/
economic-impact-analyses-fdaregulations.
VIII. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.30h that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are subject to review by OMB under the PRA 44
U.S.C. 35013521. The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
Title: Reporting Requirements to Establish, Amend, or Revoke an Import Tolerance 21 CFR 510.205
Description: The FD&C Act, as amended by the ADAA, authorizes the establishment and revocation of tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs import tolerances section 512a6 of the FD&C Act. Import tolerances provide a basis for the legal marketing of imported animal-derived food containing residues of new animal drugs neither approved nor conditionally approved in the United States unapproved new animal drugs. Without an import tolerance, any amount of residue of an unapproved new animal drug in imported, animal-

derived food would cause that food to be adulterated under section 402a2Cii of the FD&C Act because the drug would be deemed unsafe under section 512 of the FD&C Act. Such food could be denied entry into the United States under section 801a3 of the FD&C Act 21 U.S.C. 381a3. It remains unlawful to import animalderived food containing a residue of an unapproved new animal drug, unless an import tolerance has been established for such drug and any residue of the new animal drug in the imported animal-derived food does not exceed that import tolerance.
This final rule amends our regulations in part 510 to establish new information collection provisions regarding requests to establish, amend, or revoke import tolerances for residues of unapproved new animal drugs in food. This final rule establishes procedures by which a person may make such requests, as well as procedures for reconsideration of action or an administrative stay of action to establish, amend, or revoke an import tolerance. The regulations make it clear that the Commissioner may start a review process to establish, amend, or revoke an import tolerance on his or her own initiative under 10.25b. These regulations also establish when import tolerance-related actions actions resulting in establishment, amendment, or revocation and their basis will be publicly disclosed.
The information required to be submitted in a request to establish an import tolerance is set forth in 510.205e. The request must identify the drug; describe the conditions of use;
describe the proposed import tolerances for residues of the new animal drug; provide human food safety information to support the proposed import tolerances; provide other human food safety information as deemed necessary by the Commissioner;
describe practicable methods for determining the quantity, if any, of the new animal drug in or on food, and any substance formed in or on food because of its use; include an environmental assessment; and provide any
information required under 500.80
through 500.92, where applicable. The information required to be submitted in a request to amend an import tolerance is set forth in 510.205f and the information required to be submitted in a withdrawal of a request is set forth in 510.205g.
The information submitted to us in a request to establish, amend, or revoke import tolerances is necessary to allow us to establish import tolerances that would provide a basis for the legal marketing of imported animal-derived food containing residues of new animal drugs neither approved nor conditionally approved in the United States unapproved new animal drugs.
We will use the information collected through the import tolerances procedure to complete our evaluation.
Comments regarding the information collection topics solicited in the proposed rule are discussed in the preamble in section V. See, in particular, comments 4, 9, 10, 12, 18, and 19. None of the comments suggested we modify the estimated annual burden associated with the information collection. However, we have revised the analysis of the information collection provisions to accurately reflect the final rule. We added a row to table 3 to report the new burden of 510.205g withdrawal of a request, and we removed a row from table 3 to reflect that the collections of information in our procedural regulations at 21 CFR part 10 in particular, 21 CFR 10.20, 10.30, 10.33, and 10.35 already are approved under OMB control number 09100191.
Description of Respondents:
Respondents to the collection of information are: manufacturers of the unapproved new animal drug that is the subject of the request, foreign producers who use the unapproved new animal drug and their trade associations, and importers of animal-derived food bearing or containing residues of the unapproved new animal drug.
We estimate the burden of this information collection as follows:

TABLE 3ESTIMATED ANNUAL REPORTING BURDEN 1

lotter on DSK11XQN23PROD with RULES1

510.205e1 through 8; contents of request
510.205a through e; request to establish an import tolerance based on permanent Codex MRL 2
510.205a through e; request to establish an import tolerance not based on permanent Codex MRL 2
510.205f, request to amend an import tolerance
510.205g, withdrawal of a request

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Number of responses per respondent
Number of respondents
21 CFR Section; activity
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Average burden per response
Total annual responses
Total hours
2

1

2

1

2

2

1

2

50

100

1
1 1

1
1 1

1
1 1

80
32
1

80
32
1

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