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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
in 510.205, for a new animal drug application in 514.1, or

PART 20PUBLIC INFORMATION
3. The authority citation for part 20
continues to read as follows:

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19
U.S.C. 25312582; 21 U.S.C. 321393, 1401
1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u300u-5, 300aa-1.

4. In 20.100, add paragraph c47 to read as follows:

20.100 Applicability; cross-reference to other regulations.

c
47 Requests to establish or amend import tolerances, in 510.205 of this chapter.
PART 25ENVIRONMENTAL IMPACT
CONSIDERATIONS
5. The authority citation for part 25
continues to read as follows:

Authority: 21 U.S.C. 321393; 42 U.S.C.
262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR
parts 15001508; E.O. 11514, 35 FR 4247, 3
CFR, 1971 Comp., p. 531533, as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123124 and E.O. 12114, 44 FR 1957, 3
CFR, 1980 Comp., p. 356360.

6. In 25.20, add paragraph q to read as follows:

25.20 Actions requiring preparation of an environmental assessment.

q Establishment, amendment, or revocation of an import tolerance in accordance with subpart C of part 510
of this chapter.

subpart, FDA will continue to consider the compound for approval under the general safety provisions of the Federal Food, Drug, and Cosmetic Act for risks other than cancer or continue its review of the import tolerance request under the provisions of 510.201 through 510.213 of this chapter Subpart C
Import Tolerances for Residues of Unapproved New Animal Drugs in Food.

9. In 500.82b, revise the definition of Sponsor to read as follows:
500.82

b
Sponsor means the person or organization proposing or holding an approval by FDA for the use of a sponsored compound or the person initiating a request for an import tolerance under 510.205 of this chapter.

10. In 500.88, add paragraph d to read as follows:
Regulatory method.

d If the sponsor initially submitted a request for an import tolerance under 510.205 of this chapter, FDA will make the complete regulatory method for ascertaining the marker residue in the target tissue publicly available pursuant to 510.207b of this chapter.
11. In 500.92, revise paragraph a to read as follows:
500.92

Implementation.

a This subpart E applies to all new animal drug applications, food additive petitions, color additive petitions, and requests for import tolerances concerning any compound intended for use in food-producing animals including supplemental applications and amendments to petitions.

PART 500GENERAL
7. The authority citation for part 500
continues to read as follows:

Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e.

8. In 500.80, in paragraph a, add a new fourth sentence; and revise paragraph c to read as follows:

lotter on DSK11XQN23PROD with RULES1

500.80

PART 510NEW ANIMAL DRUGS
12. The authority citation for part 510
continues to read as follows:

Scope of this subpart.

a The requirements of this subpart shall also apply to a request for an import tolerance under 510.205 of this chapter.

c If FDA concludes on the basis of the threshold assessment or at a later time during the approval process or during the review of a request for an import tolerance that the data show that the sponsored compound and its metabolites should not be subject to this
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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

13. Add subpart C to read as follows:

Subpart CImport Tolerances for Residues of Unapproved New Animal Drugs in Food Sec.
510.201 Scope.
510.202 Definitions.
510.203 Initiation of a proceeding to establish or amend an import tolerance.
510.205 Content and administration of a request.

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Subpart CImport Tolerances for Residues of Unapproved New Animal Drugs in Food 510.201

Definitions.

500.88

510.206 Review of information supporting actions to establish or amend an import tolerance.
510.207 Disclosure of information submitted in a request.
510.209 Establishment, denial, or amendment of an import tolerance.
510.210 Revocation of an import tolerance.
510.212 Administrative reconsideration of action.
510.213 Administrative stay of action.

Sfmt 4700

Scope.

This subpart applies to tolerances for residues of new animal drugs not approved or conditionally approved for use in the United States, but lawfully used in another country and present in imported, animal-derived food and food products.
510.202

Definitions.

The following definitions of terms apply when used in this subpart:
CNADA means an application for conditional approval of a new animal drug submitted under section 571 of the Federal Food, Drug, and Cosmetic Act, and includes all amendments and permissible supplements.
Import tolerance means a tolerance for a residue of a new animal drug not approved or conditionally approved for use in the United States, but present in any imported edible portion of any animal.
NADA means a new animal drug application submitted under section 512
of the Federal Food, Drug, and Cosmetic Act, including all amendments and permissible supplements, for approval of a new animal drug.
Request means a request to establish or amend an import tolerance.
510.203 Initiation of a proceeding to establish or amend an import tolerance.

a Any interested person may request that the Commissioner establish or amend an import tolerance. Such a request must be in the form specified in 510.205 of this chapter.
b The Commissioner may initiate a proceeding to establish or amend an import tolerance on his or her own initiative pursuant to 10.25b of this chapter.
510.205
request.

Content and administration of a
a Pertinent information previously submitted to and currently retained in the files of the Food and Drug Administration FDA may be incorporated in, and will be considered as part of, a request on the basis of specific reference to such information. If
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