[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Rules and Regulations]
[Pages 52401-52412]
[FR Doc No: 2021-19967]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 20, 25, 500, and 510

[Docket No. FDA-2001-N-0075 (formerly Docket No. 2001N-0284)]
RIN 0910-AF78

Import Tolerances for Residues of Unapproved New Animal Drugs in
Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: 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 Review--Open for Public Comments'' or by using the
search function. All comments should be identified with the OMB control
number 0910-NEW. Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Charli Long-Medrano, Center for
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>    With regard to the information collection: JonnaLynn Capezzuto,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

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.

B. Summary of the Major Provisions of the Final Rule

    This final rule codifies procedures and food safety criteria
pertaining to the 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 Sec. Sec.  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 Sec.  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 Commissioner's 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.

D. Costs and Benefits

1. Costs of the Final Rule
    All entities affected by this final rule will incur the one-time
cost for reading and understanding this rule. Based on the small number
of firms that we estimate could request an import tolerance per year,
only about five firms would need to read and understand this rule over
the next 10 years. The total costs for reading and understanding the
rule range from around $530 to around $660. Table 1 includes a summary
of these costs.

                         Table 1--One-Time Costs for Reading and Understanding the Rule
                                                 [2020 Dollars]
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                                                                        Low           Medium           High
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Reading time (hours)............................................            0.75            0.85               1
Wage ($ per hour)...............................................         $140.30         $140.30         $140.30
Affected entities...............................................               5               5               5
Number of people reading per entity.............................               1               1               1
                                                                 -----------------------------------------------
    Total cost..................................................            $530            $585            $660
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2. Benefits of the Final Rule
    The procedures codified herein clarify the import tolerance
submission process for the establishment, amendment, and revocation of
these tolerances. This should result in improving the efficiency of the
program for both industry and government. However, we lack data to
quantify these efficiency gains.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
              Abbreviation                        What it means
------------------------------------------------------------------------
ADAA...................................  Animal Drug Availability Act of
                                          1996.
ADI....................................  Acceptable Daily Intake.
CFR....................................  Code of Federal Regulations.
CNADA..................................  Application for Conditional
                                          Approval of a New Animal Drug.
Codex MRL..............................  MRL established by the Codex
                                          Alimentarius Committee.
CVM....................................  Center for Veterinary Medicine.
FAO....................................  Food and Agriculture
                                          Organization of the United
                                          Nations.
FDA....................................  U.S. Food and Drug
                                          Administration.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act.
GMP....................................  Good Manufacturing Process.
GFI....................................  Guidance for Industry.
JECFA..................................  Joint FAO/WHO Expert Committee
                                          on Food Additives.
JMPR...................................  Joint FAO/WHO Meeting on
                                          Pesticide Residues.
MRL....................................  Maximum Residue Limit.
NADA...................................  New Animal Drug Application.
US.....................................  United States.
VICH...................................  International Cooperation on
                                          Harmonisation of Technical
                                          Requirements for Registration
                                          of Veterinary Medicinal
                                          Products.
WHO....................................  World Health Organization of
                                          the United Nations.
------------------------------------------------------------------------

III. Background

A. History and Scope of This Rulemaking

    In 1996, the President signed into law the Animal Drug Availability
Act of 1996 (ADAA) (Pub. L. 104-250), which amended the FD&C Act (21
U.S.C. 360b(a)) to authorize the establishment of 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).
    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 402(a)(2)(C)(ii) of the FD&C Act (21
U.S.C. 342(a)(2)(C)(ii)) because the drug would be deemed unsafe under
section 512 of the FD&C Act (21 U.S.C. 360b). Such food could be denied
entry into the United States under section 801(a)(3) of the FD&C Act
(21 U.S.C. 381(a)(3)). It remains unlawful to import animal-derived
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. These regulations establish procedures under
which the Agency will establish, amend, or revoke import tolerances for
residues of unapproved new animal drugs.
    The ADAA also specified that in establishing import tolerances, FDA
must rely on data sufficient to demonstrate that a proposed tolerance
is safe based on similar food safety criteria used to establish a
tolerance under a new animal drug application (NADA). For establishment
of import tolerances, food safety data can be submitted by the drug
manufacturer or be available from a relevant international organization
such as the Codex Alimentarius Commission, provided such data are not
inconsistent with criteria used to establish a tolerance for new animal
drugs in NADAs.
    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 Sec.  10.25(b). These regulations also
establish when import tolerance-related actions (actions resulting in
establishment, amendment, or revocation) and their basis will be
publicly disclosed.

B. General Overview of the Final Rule

    In issuing this rule, the Agency finalizes the provisions in the
January 2012 proposed rule (77 FR 3653, January 25, 2012). This final
rule reflects revisions the Agency made after considering all comments
received.
    This final rule amends part 510 by adding sections to establish the
scope of new subpart C (Sec.  510.201 (21 CFR 510.201)); to define
certain relevant terms (Sec.  510.202 (21 CFR 510.202)); to establish
who may initiate proceedings to establish or amend an import tolerance
(Sec.  510.203 (21 CFR 510.203)); to describe the content, options for
submission, and administration of a request to establish or amend an
import tolerance (Sec.  510.205 (21 CFR 510.205)); and to describe the
review of information to establish or amend an import tolerance (Sec.
510.206 (21 CFR 510.206)). Provisions describing when and how
information relating to import tolerances will be publicly disclosed,
previously in proposed Sec.  510.205, are now described and organized
in redesignated Sec.  510.207 (21 CFR 510.207). Procedures that FDA
follows in establishment, denial of a request for establishment, and
amendment of an import tolerance are described in redesignated Sec.
510.209 (21 CFR 510.209). Procedures for revocation of an import
tolerance are described in redesignated Sec.  510.210 (21 CFR 510.210).
Procedures for requesting reconsideration or administrative stay of a
decision to establish, amend, or revoke an import tolerance are
specified in redesignated Sec. Sec.  510.212 and 510.213 (21 CFR
510.212 and 510.213), respectively.

IV. Legal Authority

    We are issuing these regulations under the legal authority provided
by section 512(a)(6) of the FD&C Act (21 U.S.C. 360b(a)(6)) relating to
the establishment of import tolerances for unapproved new animal drugs
and under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which
gives FDA general rulemaking authority to issue regulations for the
efficient enforcement of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

    We received 17 comments on the proposed import tolerance rule by
the close of the comment period, each commenting on one or more aspects
of the proposed rule. We received comments from a wide array of members
of the public, including trade organizations, academia, public advocacy
groups, consumers, and government agencies. The comments addressed
numerous provisions of the proposed rule, including our specific
requests for comments set forth in the proposed rule. Some comments
addressed issues that are outside of the scope of this rule. Because
such comments were beyond the scope of this rule, we do not include a
discussion of them here.

A. General Comments on the Proposed Rule and FDA Response

    (Comment 1) Several comments expressed concern that establishment
of import tolerances for unapproved new animal drugs is unfair to
domestic producers who cannot legally use these drugs, thereby putting
them at a competitive disadvantage.
    (Response 1) The ADAA amended the FD&C Act to permit FDA to
establish a tolerance for residues of a new animal drug in any edible
portion of any animal imported into the United States when the intended
use of the new animal drug is not approved for use in the United
States. The legislative history notes there may be appropriate
instances (e.g., the disease treated does not exist in the United
States) in which food-producing animals in other countries are treated
with animal drugs that are not approved in the United States. Thus,
Congress enacted this provision to provide a legal means by which food
that may contain residues of these drugs may be imported into the
United States. Under the FD&C Act, lawful use of the same animal drug
in the United States requires that the new animal drug be approved or
conditionally approved by FDA. This requires additional information and
data from the sponsor to establish, among other things, that the drug
is effective for its intended use and safe for the animals receiving
the drug.
    (Comment 2) One comment states that establishing import tolerances
would result in an increase in the volume of contaminated seafood into
the United States.
    (Response 2) FDA notes that one consequence of establishing an
import tolerance may be an increase in imported edible tissues from
food-producing animals treated with the drug that is the subject of an
import tolerance. However, these imported tissues will not be permitted
entry if they contain residues above the import tolerance, the maximum
concentration of residues of the new animal drug in the edible tissues
that is determined to be safe for human consumers.
    (Comment 3) A few comments express concern that import tolerances
risk exposing U.S. consumers to unsafe tissue residues.
    (Response 3) Section 512(a)(6) of the FD&C Act requires that the
Agency rely on human food safety criteria similar to those used to
establish tolerances for approved new animal drugs when establishing
import tolerances. The human food safety criteria and review processes
resulting in establishment of tolerances for domestically approved new
animal drugs and for import tolerances for unapproved new animal drugs
are fundamentally the same. Whether the Agency is establishing an
import tolerance or a tolerance in the course of approving or
conditionally approving a new animal drug, we require data and
information to demonstrate that the residues of the new animal drug in
the edible products of treated animals are safe for human consumers.
Imported tissues will not be allowed entry into the United States if
they contain residues above the import tolerance.
    (Comment 4) One comment states that the rule should include a
requirement that the country in which the unapproved new animal drug is
legally used have an equivalent animal drug regulatory program. In
addition, a few comments recommend requiring that the requester submit:
A record of the foreign country's approval actions and the approved
uses of the new animal drug in other countries; information on
alternative treatments or competing new animal drugs and an explanation
of why the use of an unapproved new animal drug is necessary in light
of alternatives; and an affidavit that there are no FDA-approved new
animal drugs to treat the disease or condition for which the unapproved
new animal drug is indicated. The comments also recommend that the
requester be required to comply with the requirement to report adverse
drug events and that food containing such new animal drug residues
originate from a country that has approved the drug and is actively
monitoring its use.
    (Response 4) We disagree. Under the FD&C Act, to establish an
import tolerance, FDA only must consider information related to the
human food safety of the unapproved new animal drug that is the subject
of the import tolerance. The data sufficient to demonstrate that
residues of the unapproved new animal drug that is the subject of a
proposed import tolerance are safe is based on similar food safety
criteria used to establish tolerances for new animal drugs approved in
the United States. That is, the human food safety standard for
domestically approved new animal drugs and new animal drugs for which
an import tolerance is established is the same:

Reasonable certainty of no harm. The data that may be considered
include data submitted to appropriate regulatory authorities in any
country where the new animal drug is lawfully used and data available
from an appropriate international organization, to the extent such data
are not inconsistent with the criteria used to establish a tolerance
for applications for new animal drugs in the United States.
    The FD&C Act does not require the Agency to consider the use of the
drug in other countries (including the disease(s) for which the
unapproved new animal drug is indicated and whether there are approved
drugs or alternative treatments available), or that the country(ies)
where the drug is approved have an equivalent regulatory program (e.g.,
any post-approval monitoring). In addition, the FD&C Act does not
impose adverse drug event reporting requirements for the establishment
of import tolerances. Once an import tolerance is established, imported
animal-derived food that contains residues of the unapproved new animal
drug may enter the United States if those residues are below the import
tolerance. There is no requirement that the imported food originate
from a country that has approved the drug.
    (Comment 5) Two comments state that U.S. consumers should be
informed at the point of sale or through product labeling that imported
edible tissues from food-producing animals may contain residues of new
animal drugs that are not approved for use in the United States.
    (Response 5) FDA does not agree that such public disclosure is
needed to address the safety of residues from drugs for which import
tolerances are established. The purpose of the legislation was to
ensure that any edible portion of any animal imported into the United
States is safe so long as such residues are below the established
import tolerance.
    (Comment 6) One comment states that establishing import tolerances
undermines the new animal drug approval process. The commenter further
states that FDA's estimate that an import tolerance review will require
100 hours of a mid-level FDA employee's time is evidence that the
import tolerance review will be less stringent.
    (Response 6) We disagree that establishment of import tolerances
undermines the new animal drug approval process. Congress recognized
that there may be appropriate instances in which food-producing animals
in other countries are treated with animal drugs that are not approved
in the United States. For example, the disease being treated does not
exist in the United States, or the particular animal industry either
may not exist in the United States or is very small, resulting in a
limited or nonexistent market for the drug in the United States. Nor do
we agree that our estimate that an import tolerance review will
generally require 100 hours of a mid-level FDA employee's time is
evidence that import tolerance review is less stringent than review of
proposed tolerances as part of a new animal drug application. The human
food safety standard for domestically approved drugs and drugs for
which an import tolerance is established is the same: Reasonable
certainty of no harm. Whether a person is requesting that the Agency
establish an import tolerance or approve an NADA, the requester or
sponsor, respectively, is required to furnish FDA with evidence
demonstrating that the residues of the new animal drug in the edible
products of treated animals are safe for human consumption. In our
experience, it requires about 100 hours of a mid-level FDA employee's
time to review this evidence, whether submitted under a new animal drug
application or a request to establish an import tolerance.
    (Comment 7) One comment states that tolerances should only be
considered for an unapproved animal drug that is used solely for
therapeutic purposes, asserting that the ADAA was intended to establish
import tolerances for situations where a drug is used for treating
diseases and conditions that do not occur in the United States.
    (Response 7) We disagree. The plain language of the statute does
not limit the establishment of import tolerances to new animal drugs
intended to be used solely for therapeutic purposes. Generally, the
reason an animal drug developer does not seek approval of the new
animal drug in the United States (with attendant tolerances) is because
the particular animal-rearing industry may not exist in the United
States at a scale to justify the expense of seeking FDA approval. In
some cases, the new animal drug may be used for non-therapeutic
purposes.

B. Comments on Information To Support Establishment of an Import
Tolerance and FDA Response

    (Comment 8) One comment notes that the phrase ``some assurance that
the drugs are manufactured under GMP conditions,'' a comment provided
by a Veterinary Medicine Advisory Committee during a public meeting
held on this topic in January 2002, and discussed in the preamble to
the proposed rule, seems to go beyond the scope of what is necessary to
ensure public safety and should be interpreted with broad flexibility.
    (Response 8) We agree. As noted previously, section 512(a)(6) of
the FD&C Act provides that FDA shall rely on data sufficient to
demonstrate that a proposed tolerance is safe based on similar food
safety criteria used to establish tolerances for NADAs filed under
section 512(b)(1) of the FD&C Act. Section 512(a)(6) of the FD&C Act
does not require the Agency to consider other requirements, such as an
assurance of good manufacturing processes (GMPs), applicable to the new
animal drug approval process in determining whether the Agency should
grant a request to establish an import tolerance.
    (Comment 9) Two comments assert that conditions of use of
unapproved animal drugs do not need to be considered in establishing
import tolerances so long as residues in imported tissues are below the
import tolerance.
    (Response 9) We disagree. Information about the conditions of use
of the new animal drug must be considered when deciding to establish or
amend an import tolerance so that the relevance of the submitted human
food safety data, particularly tissue residues that may result from the
lawful dosing regimen, can be determined. The tissue residue
concentration is affected by the dosing regimen, i.e., the dose level
and duration for which the animal is treated. Knowing that the new
animal drug tissue concentrations reported in the human food safety
studies are the result of animals dosed under the same conditions of
use as described in the request provides FDA with assurance that the
residue data are an appropriate basis to make decisions regarding
whether to establish or amend an import tolerance.
    (Comment 10) One comment expressed concern that proposed Sec.
510.205, now Sec.  510.205(e)(5), which provides that a request for an
import tolerance may include other human food safety information as
deemed necessary by the Commissioner, is too broad, and that the
possibility of ad hoc requirements may serve to curtail the initiation
of requests or frustrate the efforts of those who do submit import
tolerance requests.
    (Response 10) The Agency does not intend to use this provision to
require more human food safety information than is necessary to assess
whether residues of unapproved new animal drugs in edible tissues of
treated animals are safe for human

consumption. The Agency will use similar criteria as for the approval
of NADAs in making its determinations, including any other information
the Commissioner deems necessary to assure safe and effective use. See
section 512(d)(1)(D) of the FD&C Act. Similarly, the Agency must ensure
that a request for a particular import tolerance includes all the
relevant information needed to make an appropriate human food safety
determination. For example, the requester may not have submitted enough
information for FDA to adequately assess the toxicity of the new animal
drug or the requester may not have provided enough detail about the
proposed analytical method. The information requested will not be ad
hoc because it must be relevant to the criteria and review standards
for human food safety, which are the same for approval of new animal
drugs and establishment of import tolerances.
    (Comment 11) One comment asks whether the Agency employs analysts
to verify the accuracy of translations of materials submitted in a
foreign language.
    (Response 11) The Agency will rely on the requester's assertion
that it is submitting a complete and accurate translation of any
materials submitted in a foreign language. As provided for in 18 U.S.C.
1001, any person, in any matter within the jurisdiction of the Agency,
who knowingly and willfully falsifies, conceals, or covers up by any
trick, scheme, or device a material fact; makes any materially false,
fictitious, or fraudulent statement or representation; or makes or uses
any false writing or document knowing the same to contain any
materially false, fictitious, or fraudulent statement or entry, may be
subject to criminal fines or imprisonment.
    (Comment 12) One comment requests that electronic submission of
import tolerance request dossiers be an option. There should be no need
for paper submissions.
    (Response 12) We agree that electronic submission of import
tolerance requests should be an option and are providing for electronic
submission of requests in Sec.  510.105(b) of this final rule. At
present, the Center for Veterinary Medicine (CVM) Office of New Animal
Drug Evaluation (ONADE) can receive and process electronic submissions
for import tolerance files. Submissions to CVM can be made after first
registering with FDA's Electronic Submissions Gateway (ESG) and CVM's
Electronic Submission System. Additional information and a user guide
on eSubmitter can be obtained at either the ``CVM eSubmitter Resource
Center'' website or the ``Getting Started with eSubmitter'' website.
Contact<EMAIL_ADDRESS>for help with the ESG or
<EMAIL_ADDRESS>for help using CVM's eSubmitter tool.
    (Comment 13) Several comments question how FDA will evaluate an
established acceptable daily intake (ADI), especially considering
different food consumption patterns of different countries. Comments
also question whether FDA considers subpopulations, such as children
and immune-compromised people who may be particularly sensitive to the
effects of exposure to drug residues. Comments express concerns that
safety standards are being loosened and unsafe residues will be allowed
in foods.
    (Response 13) The ADI established for residues of an unapproved new
animal drug in edible tissues of food-producing animals that is used in
evaluating an import tolerance request is based on the same toxicity
data and information as is used to establish an ADI for a domestically
approved new animal drug and is evaluated using the same standards and
methodology that is used for a domestic drug approval. The toxicity
data that FDA uses to determine the ADI are described in guidances
available on our website (https://www.fda.gov/animal-veterinary/guidance-industry/human-food-safety-guidances). The guidances for
toxicology studies are documents that are internationally harmonized
through the International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH)
Expert Working Groups. The ADI, expressed in a micrograms or milligrams
of the new animal drug per kilogram of body weight per day ([micro]g/kg
bw/day or mg/kg bw/day), is the amount of drug residue that can be
consumed on a daily basis for up to a lifetime without adverse effects
or harm to the health of a consumer.
    The ADI is meant to be applied to a general population, including
sensitive subpopulations. The ADI determination uses conservative
procedures to ensure that the final value is protective of a general
population, such as application of a safety factor to account for human
variability in sensitivity to the toxicity of the new animal drug, and
tests for specific subpopulations if needed (asthmatic persons,
allergic persons, etc.). Additionally, the application of the ADI to
safe concentrations of the drug residues in edible tissues uses a lower
average human body weight (60 kg) and conservative estimates of food
consumption, such as a high milk consumption factor of 1.5 liter per
day. Therefore, the Agency believes using the same methodology to
calculate ADI for import tolerances as U.S.-approved animal drugs is
appropriate.
    (Comment 14) One comment states that the rule should explicitly
prohibit the setting of import tolerances for residues of new animal
drugs that induce cancer when ingested by humans or animals.
    (Response 14) We disagree that the rule should explicitly prohibit
the Agency from considering new animal drugs of carcinogenic concern
(new animal drugs that induce cancer when ingested by people or
animals). Section 512(a)(6) of the FD&C Act provides FDA the authority
to consider requests to establish import tolerances using food safety
criteria similar to those that are applied to the approval of new
animal drugs. Under section 512(d)(1)(I) of the FD&C Act, the Agency
may approve NADAs for drugs of carcinogenic concern as long as the
compound does not adversely affect the animals and no residue of a
carcinogenic compound will be found in food produced from those
animals. Pursuant to section 512(a)(6) of the FD&C Act, FDA will
consider requests for import tolerances for animal drugs of
carcinogenic concern using similar food safety criteria as it would for
a new animal drug application for approval. Thus, if FDA determines
that a new animal drug for which an import tolerance request has been
submitted is a new animal drug of carcinogenic concern, the requester
will be directed to comply with the ``no residue'' requirements of
Sec. Sec.  500.80 through 500.92 (21 CFR part 500, subpart E,
Regulation of Carcinogenic Compounds Used in Food-Producing Animals).
Any regulatory method for ascertaining the marker residue in the target
tissue will be made publicly available pursuant to Sec.  510.207(b) of
the final rule. We have revised Sec. Sec.  510.205(e) and 510.207(b) of
the final rule and made conforming changes to Sec. Sec.  500.80,
500.82, 500.88, and 500.92 to clarify the process for evaluating a new
animal drug of carcinogenic concern under these circumstances.
    (Comment 15) One comment states that the rule should specifically
prohibit the setting of import tolerances for antimicrobial animal
drugs that are in the same classes as drugs used in human medicine.
    (Response 15) We disagree. Rather than declining to establish
import tolerances for residues of antimicrobial new animal drugs that
are in the same classes as drugs used in human medicine, we intend to
apply the same

human food safety standard (reasonable certainty of no harm) as we
apply to all new animal drugs, including antimicrobial new animal
drugs, seeking approval under an NADA or application for conditional
approval of a new animal drug (CNADA). For requests for import
tolerances for antimicrobials, FDA evaluates the impacts on human
health, including the potential transmission of antimicrobial resistant
bacteria of human health concern through the consumption of animal-
derived food products. To assess these impacts, FDA recommends
conducting the qualitative risk assessment described in Guidance for
Industry (GFI) #152 entitled ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to Their Microbiological Effects on
Bacteria of Human Health Concern,'' October 23, 2003.\1\ In addition,
we recommend that requesters address the step-wise approach outlined in
GFI #159 (VICH GL36), ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Establish a
Microbiological ADI,'' March 5, 2013,\2\ to assure the Agency that any
impacts of antimicrobial new animal drug residues on the intestinal
flora of human consumers are minimal. By addressing these important
human food safety endpoints for antimicrobial new animal drugs,
requesters will be able to assure the Agency that the imported animal-
derived food products are safe for human consumption.
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/media/69949/download.
    \2\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-159-vich-gl36-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach.
---------------------------------------------------------------------------

    (Comment 16) A comment stated that the rule should specifically
prohibit the setting of import tolerances for veterinary drugs that
have extralabel use restrictions in the United States or that are
banned from use in domestic livestock enterprises (including
aquaculture).
    (Response 16) As noted previously, whether a person is requesting
the Agency establish an import tolerance or approve an NADA, the
requester or sponsor, respectively, is required to furnish FDA with
evidence demonstrating that the residues of the new animal drug in the
edible products of treated animals are safe for human consumption. If
the requester can satisfy the human food safety requirements, the
Agency may establish an import tolerance for a food-producing species
for which there is no extralabel use restriction, even if an extralabel
use prohibition exists for other food-producing species.
    (Comment 17) One comment requests that the requirement that the
unapproved animal drug be registered (lawfully used) in another country
should be revised to allow a request for an import tolerance to
simultaneously progress with registration of the drug in foreign
countries.
    (Response 17) The statute gives us discretion to ``consider and
rely on data submitted by the drug manufacturer, including data
submitted to appropriate regulatory authorities in any country where
the new animal drug is lawfully used.'' As we noted in the preamble to
the proposed rule, the Agency has interpreted this statutory language
to mean that we may establish an import tolerance for a new animal drug
that is not approved or conditionally approved in the United States but
that is lawfully used in another country. Thus, foreign lawful use in
at least one country must occur before a request to establish an import
tolerance is submitted to the Agency.
    (Comment 18) One comment requests that FDA revise the evidentiary
standard for revocation of an import tolerance to be ``evidence to show
a reasonable basis from which serious questions may be inferred about
the ultimate safety of the unapproved new animal drug residue and any
substance that may be formed as a result of the unapproved new animal
drug's use.'' The comment raises the concern that the proposed rule
appears to require consumers to bring conclusive evidence to obtain a
review of the import tolerance.
    (Response 18) We disagree. The standard for revoking an import
tolerance is provided for in section 512(a)(6) of the FD&C Act, which
states that the Agency may revoke an import tolerance ``if information
demonstrates that the use of the new animal drug under actual use
conditions results in food being imported into the United States with
residues exceeding the tolerance or if scientific evidence shows the
tolerance to be unsafe.'' The final rule reflects this standard in
Sec.  510.210(a). An import tolerance can be revoked upon petition or
by the initiative of the Commissioner.

C. Comments on Environmental Review and FDA Response

    (Comment 19) In the preamble to the proposed rule, the Agency
requested comments and supporting information relevant to the issue of
whether import tolerances will have a significant effect on the
environment in the United States or abroad. FDA received two comments
indicating that available information shows that FDA's establishment of
import tolerances should present no appreciable risk to the environment
from either the consumption or disposal of edible tissues containing
residues of animal drugs. Two comments support creation by FDA of a
categorical exclusion from the requirement to prepare an environmental
assessment (EA) for an import tolerance request. For example, one
comment presents evidence why risks to the environment should not be
significant, showing calculations and summarizing information
indicating that residues in certain media (e.g., wastewater, soil)
would be below threshold criteria already established by FDA in
guidance documents or in existing categorical exclusions for other
actions. Thus, the basis for establishing a new categorical exclusion
for import tolerances is already in place.
    (Response 19) We agree with the comments' assessment of the low
risk of significant environmental impacts from either the consumption
or disposal of edible tissues containing residues of animal drugs.
Since the 2012 proposed rule, we have reviewed EAs for several import
tolerance requests for new animal drugs used in both aquatic and
terrestrial environments (aquatic: Azamethiphos and lufenuron in
salmonids, benzocaine in Atlantic salmon and rainbow trout, and
emamectin and teflubenzuron in Atlantic salmon; terrestrial: Monensin
and monepantel in sheep; see https://www.fda.gov/AnimalVeterinary/Products/ImportExports/ucm315830.htm). Regardless of the environment in
which the drugs were used, each EA described the introduction of drug
residues into the domestic environment as being through the consumption
of food resulting in: (1) Excreta entering sewage treatment facilities
and (2) waste of edible tissues disposed of in landfills. Each EA
resulted in a finding by the Agency of no significant environmental
impact; thus, for each import tolerance action a finding of no
significant impact was prepared.
    In response to comments that FDA create a categorical exclusion
from the requirement to prepare an EA for an action on an import
tolerance, the Agency is considering proposing a new categorical
exclusion specific to establishment, amendment, or revocation of an
import tolerance. This would require review by the White House Council
on Environmental Quality, as well as additional rulemaking with public
notice and comment. The Agency is currently evaluating available
information to

determine if this category of actions would individually or
cumulatively result in significant effects on the environment and will
proceed as appropriate.
    (Comment 20) One comment notes that establishment of an import
tolerance should also have no appreciable environmental effect outside
the United States. If the new animal drug is not expected to have
significant environmental impacts in the country where it is registered
for use, it is hard to imagine a situation where movement of residues
to another country or into the global commons, such as the open ocean,
would present a significant environmental risk.
    (Response 20) We agree with the comment's assessment of the low
risk of significant environmental effects abroad of residues of new
animal drugs appropriately registered in the country they are used
based on our experience to date. An analysis of effects abroad is not
currently required in the EA for establishment of an import tolerance;
however, when necessary, such an analysis will be completed by the
Agency.

VI. Effective Date

    The rule is effective January 19, 2022.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the final rule will simply codify the procedures that
are currently used for the import tolerance program, we certify that
the final rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
Summary of Cost and Benefits
    Firms are currently able to request that we establish or amend an
import tolerance. The final rule will not change the current procedures
for these requests. Thus, we include only the incremental costs of
reading and understanding the final rule on import tolerance
procedures.
    In table 2, FDA provides the Regulatory Information Service Center
and Office of Information and Regulatory Affairs Consolidated
Information Center accounting information.

                                                  Table 2--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                             ------------------------------------
                Category                    Primary       Low        High                               Period                     Notes
                                           estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized, Monetized $millions/year  ..........  ..........  ..........  ..........           7  ..........  ......................................
                                          ..........  ..........  ..........  ..........           3  ..........  ......................................
    Annualized Quantified...............  ..........  ..........  ..........  ..........           7  ..........  ......................................
                                          ..........  ..........  ..........  ..........           3  ..........  ......................................
                                         ---------------------------------------------------------------------------------------------------------------
    Qualitative.........................  Codifying current practices of the
                                          import tolerance program could
                                          improve the efficiency of the
                                          program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized, Monetized $millions/year    <$0.0001    <$0.0001    <$0.0001        2020           7          10  ......................................
                                            <$0.0001    <$0.0001    <$0.0001        2020           3          10  ......................................
    Annualized..........................  ..........  ..........  ..........  ..........           7  ..........  ......................................
    Quantified..........................  ..........  ..........  ..........  ..........           3  ..........  ......................................
    Qualitative.........................  ..........  ..........  ..........  ..........  ..........  ..........  ......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized          ..........  ..........  ..........  ..........           7  ..........
     $millions/year.
                                          ..........  ..........  ..........  ..........           3  ..........
                                         ---------------------------------------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
                                         ---------------------------------------------------------------------------------------------------------------
    Other...............................  ..........  ..........  ..........  ..........           7  ..........  ......................................
    Annualized, Monetized $millions/year  ..........  ..........  ..........  ..........           3  ..........  ......................................
                                         ---------------------------------------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No Effect........................................................................................................
    Small Business: The final rule will not have a significant impact on a substantial number of small entities that manufacture unapproved drugs that
     are the subject of an import tolerance request..
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 (FDA-2001-N-
0075) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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. 3501-3521). 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
512(a)(6) 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 402(a)(2)(C)(ii) 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 801(a)(3) of the FD&C
Act (21 U.S.C. 381(a)(3)). It remains unlawful to import animal-derived
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
Sec.  10.25(b). 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 Sec.  510.205(e). The request must
identify the drug; describe the conditions of use; describe the
proposed import tolerance(s) for residues of the new animal drug;
provide human food safety information to support the proposed import
tolerance(s); 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
Sec. Sec.  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 Sec.  510.205(f) and the information required to be
submitted in a withdrawal of a request is set forth in Sec.
510.205(g).
    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 Sec.  510.205(g)
(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 0910-0191.
    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 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR Section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
510.205(e)(1) through (8);                     2               1               2               1               2
 contents of request............
510.205(a) through (e); request                2               1               2              50             100
 to establish an import
 tolerance based on permanent
 Codex MRL \2\..................
510.205(a) through (e); request                1               1               1              80              80
 to establish an import
 tolerance not based on
 permanent Codex MRL \2\........
510.205(f), request to amend an                1               1               1              32              32
 import tolerance...............
510.205(g), withdrawal of a                    1               1               1               1               1
 request........................

    Total.......................  ..............  ..............  ..............  ..............             215
----------------------------------------------------------------------------------------------------------------
\1\ There 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 Agency's
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 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 3507(d) of the PRA.
Before the effective date of this final rule, FDA will publish a notice
in the Federal Register announcing OMB's 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 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 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

0
2. In Sec.  10.25, revise paragraph (a)(1) to read as follows:

Sec.  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 Sec.  71.1, for a food
additive petition in Sec.  171.1 or Sec.  571.1, for a new drug
application in Sec.  314.50, for a request to establish or amend an
import tolerance

in Sec.  510.205, for a new animal drug application in Sec.  514.1, or
* * * * *

PART 20--PUBLIC INFORMATION

0
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. 2531-2582; 21
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

0
4. In Sec.  20.100, add paragraph (c)(47) to read as follows:

Sec.  20.100   Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (47) Requests to establish or amend import tolerances, in Sec.
510.205 of this chapter.

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
5. The authority citation for part 25 continues to read as follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42
U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3
CFR, 1971 Comp., p. 531-533, as amended by E.O. 11991, 42 FR 26967,
3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR,
1980 Comp., p. 356-360.

0
6. In Sec.  25.20, add paragraph (q) to read as follows:

Sec.  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.

PART 500--GENERAL

0
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.

0
8. In Sec.  500.80, in paragraph (a), add a new fourth sentence; and
revise paragraph (c) to read as follows:

Sec.  500.80   Scope of this subpart.

    (a) * * * The requirements of this subpart shall also apply to a
request for an import tolerance under Sec.  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 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 Sec. Sec.  510.201 through 510.213 of
this chapter (Subpart C--Import Tolerances for Residues of Unapproved
New Animal Drugs in Food).
* * * * *

0
9. In Sec.  500.82(b), revise the definition of ``Sponsor'' to read as
follows:

Sec.  500.82   Definitions.

* * * * *
    (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 Sec.  510.205 of
this chapter.
* * * * *

0
10. In Sec.  500.88, add paragraph (d) to read as follows:

Sec.  500.88   Regulatory method.

* * * * *
    (d) If the sponsor initially submitted a request for an import
tolerance under Sec.  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 Sec.  510.207(b) of this
chapter.

0
11. In Sec.  500.92, revise paragraph (a) to read as follows:

Sec.  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 510--NEW ANIMAL DRUGS

0
12. The authority citation for part 510 continues to read as follows:

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

0
13. Add subpart C to read as follows:
Subpart C--Import 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.
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.

Subpart C--Import Tolerances for Residues of Unapproved New Animal
Drugs in Food

Sec.  510.201   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.

Sec.  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.

Sec.  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 Sec.  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
Sec.  10.25(b) of this chapter.

Sec.  510.205  Content and administration of a request.

    (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

the requester refers to any nonpublic information other than its own,
the requester shall obtain a written right of reference to that
nonpublic information and submit the right of reference with the
request. Any reference to published information offered in support of a
request should be accompanied by reprints or copies of such references.
    (b) Requests shall be submitted and addressed to the Document
Control Unit (HFV-199), Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855. Requests may be
submitted in an electronic format as authorized by FDA. See FDA's
Electronic Submissions Gateway website: https://www.fda.gov/industry/electronic-submissions-gateway.
    (c) Any material submitted in a foreign language shall be
accompanied by a complete and accurate English translation.
Translations of literature printed in a language other than English
shall be accompanied by copies of the original publication.
    (d) The request must be dated and must be signed by the requester
or by his or her authorized attorney, agent, or official and shall
state the requester's correspondence address. If the requester or such
authorized representative does not reside or have a place of business
within the United States, the requester must also furnish the name and
post office address of, and the request must be countersigned by, an
authorized attorney, agent, or official residing or maintaining a place
of business within the United States.
    (e) The request must include the following information:
    (1) The established name and all pertinent information concerning
the new animal drug, including chemical identity and composition of the
new animal drug, and its physical, chemical, and biological properties;
    (2) The conditions of use for the new animal drug, including the
route of administration and dosage, together with all labeling,
directions, and recommendations regarding the uses in countries in
which the new animal drug is lawfully used;
    (3) The proposed import tolerance(s) for residues of the new animal
drug;
    (4) Human food safety information to support the proposed import
tolerance(s) in either of the following forms:
    (i) If a permanent maximum residue limit (MRL) has been established
by the Codex Alimentarius Committee (Codex MRL), the requester shall
provide the permanent Codex MRL and monographs and reports from the
Joint Expert Committee on Food Additives (JECFA) of the Food and
Agriculture Organization (FAO) and the World Health Organization (WHO)
of the United Nations and/or monographs and reports from the Joint FAO/
WHO Meeting on Pesticide Residues (JMPR) that support the development
of the permanent Codex MRL. FDA may request additional information as
needed.
    (ii) If no permanent Codex MRL has been established, or upon
notification by FDA, the requester must provide full reports of
investigations made with respect to the human food safety of the new
animal drug. A request may be regarded as incomplete unless it includes
full reports of adequate tests by all methods reasonably applicable to
show whether or not any imported edible portion of any animal receiving
the new animal drug will be safe for human consumption. The reports
must include detailed data derived from appropriate animal and other
biological experiments in which the methods used and the results
obtained are clearly set forth, including data submitted to the
appropriate regulatory authority in any country where the new animal
drug is lawfully used. The request must also include a statement that
all such reports have been submitted or contain an explanation of why
such reports were not submitted. With respect to each nonclinical
laboratory study contained in the request, the requestor must submit
either a statement that the study was conducted in compliance with the
good laboratory practice regulations set forth in part 58 of this
chapter, or, if the study was not conducted in compliance with such
regulations, a brief statement of the reason for the noncompliance, and
how this may have impacted the study;
    (5) Other human food safety information as deemed necessary by the
Commissioner;
    (6) A description of 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;
    (7) An environmental assessment under Sec.  25.40 of this chapter;
and
    (8) Any information required under Sec. Sec.  500.80 through 500.92
of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used
in Food-Producing Animals), where applicable.
    (f) A request to amend an established import tolerance must contain
information to support each proposed change. The request may omit
statements made in the original request for which no change is
proposed.
    (g) The requester may withdraw the request at any time before the
notification provided for in Sec.  510.207(a) of this chapter has been
made publicly available.

Sec.  510.206  Review of information supporting actions to establish or
amend an import tolerance.

    In establishing or amending an import tolerance, the Commissioner
shall rely on data sufficient to demonstrate that a proposed tolerance
is safe based on similar food safety criteria used by the Commissioner
to establish tolerances for applications for new animal drugs filed
under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. In
establishing or amending an import tolerance, the Commissioner will
give appropriate consideration to the anticipated residue
concentrations and conditions of use of the new animal drug specified.

Sec.  510.207  Disclosure of information submitted in a request.

    (a) When a request is determined to be complete for FDA's
consideration, the Commissioner will provide public notification of the
request containing the name of the requester and a brief description of
the request in general terms. A copy of the notification will be sent
to the requester at the time the information is made available to the
public.
    (b) Any notification establishing, amending, or revoking an import
tolerance will be made publicly available. A summary of the basis for
the decision will be publicly released in accordance with the
provisions of part 20 of this chapter. If FDA determines that the new
animal drug referred to in the request is a new animal drug that
induces cancer when ingested by people or animals, and the requester
complies with the requirements of Sec. Sec.  500.80 through 500.92 of
this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in
Food-Producing Animals), the regulatory method for ascertaining the
marker residue in the target tissue will be made publicly available.
All information and safety data submitted with the request, or
previously submitted information incorporated in, and considered as
part of, a request on the basis of specific reference to such
information, shall be available for public disclosure, also in
accordance with the provisions of part 20 of this chapter. Trade
secrets and confidential commercial or financial information are
exempted from release under Sec.  20.61 of this chapter.

Sec.  510.209   Establishment, denial, or amendment of an import
tolerance.

    (a) If an import tolerance is established or amended, the

Commissioner will provide public notification of the action, which will
be effective from the date of public notification. A copy of the
notification will be sent to any requestor at the time the information
is made available to the public.
    (b) If a request to establish or amend an import tolerance is
denied, a notification of the denial will be made publicly available,
and a copy of the denial letter, including the reasons for such action,
will be sent to the requester.
    (c) A tolerance established in an approved NADA or conditionally
approved CNADA will supersede an existing import tolerance. In the
event the conditionally approved CNADA is not renewed or is withdrawn,
or such drug does not achieve approval under section 512 of the Federal
Food, Drug, and Cosmetic Act within 5 years following the date of the
conditional approval, the Agency will reinstate the import tolerance
unless Sec.  510.210(a)(1) or (a)(2) is applicable at that time.

Sec.  510.210  Revocation of an import tolerance.

    (a) The Commissioner, on his or her own initiative or on the
petition of an interested person, under Sec.  10.25 of this chapter,
may revoke an import tolerance if:
    (1) Scientific evidence shows an import tolerance to be unsafe; or
    (2) Information demonstrates that the use of a new animal drug
under actual use conditions results in food being imported into the
United States with residues exceeding the import tolerance.
    (b) The Commissioner will provide public notification under Sec.
510.207(b) that will specify the basis for the decision and will be
effective at the time the information is made available to the public.
    (c) A petition for revocation must be submitted in the form
specified in Sec.  10.30 of this chapter.

Sec.  510.212  Administrative reconsideration of action.

    (a) The Commissioner may at any time, on his or her own initiative
or on the petition of an interested person under part 10 of this
chapter, reconsider part or all of a decision to establish, not
establish, amend, or revoke an import tolerance.
    (b) A petition for reconsideration must be submitted in accordance
with Sec.  10.20 of this chapter and in the form specified in Sec.
10.33 of this chapter no later than 30 days after the date of public
notification of the decision involved. The Commissioner may, for good
cause, permit a petition to be filed more than 30 days after public
notification of the decision. The petition for reconsideration must
demonstrate that relevant information contained in the administrative
record was not previously or not adequately considered by the
Commissioner. No new information may be included in a petition for
reconsideration.
    (c) An interested person who wishes to rely on information not
included in the administrative record shall submit either a petition to
amend an import tolerance under Sec.  510.205 or to revoke an import
tolerance under Sec.  510.210 and Sec.  10.25 of this chapter.

Sec.  510.213   Administrative stay of action.

    (a) The Commissioner may at any time, on his or her own initiative
or on the request of an interested person under part 10 of this
chapter, stay or extend the effective date of a decision to establish,
not establish, amend, or revoke an import tolerance.
    (b) A request for stay must be submitted in accordance with Sec.
10.20 of this chapter and in the form specified in Sec.  10.35 of this
chapter no later than 30 days after public notification of the decision
involved. The Commissioner may, for good cause, permit a petition to be
filed more than 30 days after public notification of the decision.

    Dated: September 10, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-19967 Filed 9-20-21; 8:45 am]
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[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Notices]
[Pages 74168-74169]
[FR Doc No: 2014-29284]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2002-12844]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
7 individuals. FMCSA has statutory authority to exempt individuals from
the vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemption renewals
will provide a level of safety that is equivalent to or greater than
the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

DATES: This decision is effective January 17, 2015. Comments must be
received on or before January 14, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2002-
12844], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue, SE., Room W64-
224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5
p.m. Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

II. Exemption Decision

    This notice addresses 7 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 7 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Howard F. Breitkreutz (MN)
John E. Evenson (WI)
Steven C. Humke (IA)
Craig M. Landry (LA)
Andrew H. Rusk (IL)
Kenneth E. Vigue, Jr. (WA)
Richard A. Winslow (MN)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) the person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it

was granted; or (3) continuation of the exemption would not be
consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 7 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (67 FR 68719; 68 FR 2629; 69 FR 71100; 72 FR 1053; 73 FR
76440; 75 FR 80887; 77 FR 76167). Each of these 7 applicants has
requested renewal of the exemption and has submitted evidence showing
that the vision in the better eye continues to meet the requirement
specified at 49 CFR 391.41(b)(10) and that the vision impairment is
stable. In addition, a review of each record of safety while driving
with the respective vision deficiencies over the past two years
indicates each applicant continues to meet the vision exemption
requirements.
    These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

IV. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2002-12844), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so the Agency can contact you if it has questions regarding
your submission.
    To submit your comment online, got to http://www.regulations.gov
and put the docket number, ``FMCSA-2002-12844'' in the ``Keyword'' box,
and click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may change this notice based on your
comments.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble as being available in the docket, go to http://www.regulations.gov and in the search box insert the docket number,
``FMCSA-2002-12844'' in the ``Keyword'' box and click ``Search.'' Next,
click ``Open Docket Folder'' button choose the document listed to
review. If you do not have access to the Internet, you may view the
docket online by visiting the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

    Issued on: December 5, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-29284 Filed 12-12-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72243-72244]
[FR Doc No: 2014-28542]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2014-0122]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to renew an information collection. Before a Federal
agency can collect certain information from the public, it must receive
approval from the Office of Management and Budget (OMB). Under
procedures established by the Paperwork Reduction Act of 1995, before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatement of previously approved collections.

DATES: Written comments should be submitted by February 3, 2015.

ADDRESSES: You may submit comments [identified by Docket No. DOT-OST-
200X-XXXX] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE., West
Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Walter Culbreath,<PHONE_NUMBER>, Office
of the Chief Information Officer, U.S. Department of Transportation,
1200 New Jersey Avenue SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2127-0682
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery
    Type of Review: Renewal of an information collection.
    Abstract: The proposed information collection activity provides a
means to garner qualitative customer and stakeholder feedback in an
efficient, timely manner, in accordance with the Administration's
commitment to improving service delivery.
    This feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
    The solicitation of feedback will target areas such as: Timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
    The Agency will only submit a collection for approval under this
generic clearance if it meets the following conditions:
     The collections are voluntary;
     The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
     The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
     Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the agency (if
released, the agency must indicate the qualitative nature of the
information);
     Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
     Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
    Feedback collected under this generic clearance provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: The target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be

eligible for submission for other generic mechanisms that are designed
to yield quantitative results.
    As a general matter, information collections will not result in any
new system of records containing privacy information and will not ask
questions of a sensitive nature, such as sexual behavior and attitudes,
religious beliefs, and other matters that are commonly considered
private.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Estimated number of Respondents: 162,350.
    Frequency: Once per request.
    Number of Responses: 162,350.
    Estimated Total Annual Burden: 83,191.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information. The agency
will summarize and/or include your comments in the request for OMB's
clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

Kevin Mahoney,
Director, Office of Corporate Customer Services.
[FR Doc. 2014-28542 Filed 12-4-14; 8:45 am]
BILLING CODE 4910-59-P