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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Rules and Regulations
52401

Name of Product/Data/Publication/Information/Service Current fee
New fee
NOAA National Center for Environmental Information Provision of Global Nighttime VIIRS day/night band data in HDF5 format
Provision of regional data from the VIIRS instrument on a daily basis

29,975.00
14,720.00

Indicates a product no longer offered.

Docket No. FDA2001N0075 formerly Docket No. 2001N0284

Medicine HFV150, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 2404020850, charli.long-medrano@fda.hhs.gov.
With regard to the information collection: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601 Landsdown St., North Bethesda, MD 20852, 301796
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

RIN 0910AF78

Table of Contents
FR Doc. 202120194 Filed 92021; 8:45 am BILLING CODE 3510HRP

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Parts 10, 20, 25, 500, and 510

Import Tolerances for Residues of Unapproved New Animal Drugs in Food AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final rule.

The Food and Drug Administration FDA, the Agency, we is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States import tolerances. These import tolerances provide a basis for the legal marketing of such animal-derived food.
DATES: This rule is effective January 19, 2022. Submit written comments including recommendations on information collection issues under the Paperwork Reduction Act of 1995 PRA
by October 21, 2021 see section IX, the Paperwork Reduction Act of 1995
section of this document.
ADDRESSES: To ensure that comments on the information collection are received, the Office of Management and Budget OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. All comments should be identified with the OMB control number 0910NEW. Also include the FDA docket number found in brackets in the heading of this document.

lotter on DSK11XQN23PROD with RULES1

SUMMARY:

I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. History and Scope of This Rulemaking B. General Overview of the Final Rule IV. Legal Authority V. Comments on the Proposed Rule and FDA
Response A. General Comments on the Proposed Rule and FDA Response B. Comments on Information To Support Establishment of an Import Tolerance and FDA Response C. Comments on Environmental Review and FDA Response VI. Effective Date VII. Economic Analysis of Impacts VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995
X. Federalism XI. Consultation and Coordination With Indian Tribal Governments
I. Executive Summary A. Purpose of the Final Rule This rule codifies procedures and food safety criteria by which tolerances for residues of unapproved new animal drugs in any edible portion of any animal imported into the United States import tolerances may be established or amended. These import tolerances provide a basis for the legal marketing of such animal-derived food. The regulation also specifies procedures by which import tolerances may be revoked.

FOR FURTHER INFORMATION CONTACT:

B. Summary of the Major Provisions of the Final Rule
With regard to the final rule: Charli Long-Medrano, Center for Veterinary
This final rule codifies procedures and food safety criteria pertaining to the
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establishment, amendment, and revocation of import tolerances in new subpart C of part 510 of the Code of Federal Regulations 21 CFR part 510.
Major provisions include:
The scope and definitions;
who may initiate proceedings to establish an import tolerance;
contents of a submission requesting establishment of an import tolerance;
sources of data and information supporting the safety of a proposed import tolerance;
Agency procedures for establishment, amendment, or revocation of an import tolerance;
public disclosure of import tolerance-related actions actions under consideration, establishment, amendment, or revocation; and environmental impact assessment of import tolerance-related actions.
In addition, conforming amendments are being made in 10.25, 20.100, 25.20, 500.80, 500.82, 500.88, and 500.92 21 CFR 10.25, 20.100, 25.20, 500.80, 500.82, 500.88, and 500.92. A
technical amendment is being made in 10.25 21 CFR 10.25 to include food additive petitions under 21 CFR 571.1
in the non-exhaustive list of petitions specified in FDA regulations.
The procedures and food safety criteria in the final rule are fundamentally the same as in the proposed rule; however, the final rule has been minimally reorganized to clarify that import tolerances established at the Commissioners initiative follow the same procedures as those established at the request of an interested person. We have also made nonsubstantive wording changes for clarity.
C. Legal Authority Our authority for issuing this final rule is provided by the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act FD&C Act by which we establish tolerances for residues of new animal drugs and under provisions of the FD&C Act that give the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

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