[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Proposed Rules]
[Pages 38666-38669]
[FR Doc No: 2018-16807]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 /
Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2018-N-2610]

Future Format of the National Drug Code; Public Hearing; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing and an opportunity for public comment on
the future format of the National Drug Code (NDC). FDA is seeking input
from a variety of stakeholders through comments and responses to FDA
questions included in this notice and associated web content to be
published ahead of the hearing. The questions are intended to allow FDA
to obtain stakeholders' perspectives on the impact of any future
changes made to the length and format of the NDC.

DATES: The public hearing will be held on November 5, 2018, from 8:30
a.m. to 5 p.m. The hearing may be extended or end early depending on
the level of public participation. Persons seeking to attend or present
at the public hearing must register by October 15, 2018. Electronic or
written comments will be accepted after the public hearing until
January 5, 2019.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503 Section B and C), Silver Spring, MD 20993-0002. Entrance for
the public hearing participants (non-FDA employees) is through Building
1, where routine security check procedures will be performed. For
parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2610 for ``Future Format of the National Drug Code; Public
Hearing; Request for Comments.'' Received comments, those filed in a
timely manner (see DATES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Leyla Rahjou-Esfandiary, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993, 301-796-
3185, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The NDC is an FDA standard for uniquely identifying drugs in the
United States. Currently, NDCs assigned by FDA contain 10 digits. As
described in Sec.  207.33(b) (21 CFR 207.33(b)), NDCs consist of three
segments: the labeler code, the product code, and the package code. At
some point in the next 10 to 15 years, NDC formatting will need to be
updated to accommodate longer NDCs because new labelers are continually
entering the U.S. market. In 2016, when FDA published the
``Requirements for Foreign and Domestic Establishment Registration and
Listing for Human Drugs, Including Drugs That Are Regulated Under a
Biologics License Application, and Animal Drugs, Final Rule'' FDA
stated that when it runs out of 5-digit labeler codes, it will begin
assigning 6-digit labeler codes. (81 FR 60170, August 31, 2016). As a
result, FDA will add two new 11-digit NDC formats to accommodate the
longer labeler codes. However, FDA acknowledged that some stakeholders
expressed an interest in FDA moving to a single, standard format for
NDCs and announced that it would initiate a public discussion of future
formatting options (81 FR 60170 at 60187). Because of the widespread
use and dependency on NDCs in prescribing, dispensing, reimbursement,
safety, clinical management, supply chain management, and
pharmaceutical manufacturing and labeling systems, the Agency is
holding a public hearing and requesting comments from stakeholders on
the impact of the transition to 6-digit labeler codes.
    Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360) requires each registered drug establishment to provide
FDA with a current list of all drugs manufactured, prepared,
propagated, compounded, or processed by the establishment for
commercial distribution. Drug products are identified and reported
using the NDC.
    The NDC for each listed drug in the United States is a unique 10-
digit, 3-segment number. The 3 segments of NDC include the labeler
code, product code, and package code. A labeler code is a unique 4-, 5-
, or (in the future) 6-digit number assigned by FDA that identifies the
manufacturer, repacker, relabeler, or private label distributor of the
drug. The second segment, the product code, identifies a specific
strength, dosage form, and formulation of a drug manufactured,
repackaged, relabeled, or distributed by the labeler. The third
segment, the package code, identifies package sizes and types.
Different package codes only differentiate between different
quantitative and qualitative attributes of the product packaging. Both
the product and package codes are proposed by persons submitting drug
listing information. FDA will assign a proposed NDC if it has not been
used previously, is not currently in use, and has not been reserved for
future assignment to a different product. The NDC for a given drug is
currently in one of the following configurations (with each number
representing the number of digits in that segment): 4-4-2, 5-3-2, or 5-
4-1.
    According to current regulations, labeler codes may consist of 4,
5, or 6 digits (Sec.  207.33(b)(1)). Currently, 5-digit labeler codes
are being assigned by FDA. A 5-digit labeler code format provides FDA
with 90,000 labeler codes that could be assigned to drug manufacturers
and private label distributors ranging from 10,000 to 99,999. Based on
current assignment rates, FDA anticipates that it will run out of 5-
digit labeler codes in approximately 15 years. FDA will begin assigning
6-digit labeler codes at some point in the future due to exhaustion of
5-digit labeler codes. Moving up to 6-digit labeler codes will expand
NDCs to 11 digits and, per regulation, allows for two additional NDC
configurations: 6-3-2 and 6-4-1, for a total of five possible NDC
configurations (including the three 10-digit NDC configurations).
    The Health Insurance Portability and Accountability Act (HIPAA)
(Pub. L. 104-191) contains provisions calling for the administrative
simplification ``of the national standards for electronic health care
transactions and code sets, unique health identifiers, and security''
\1\ and specifically references the NDC. In its implementation of these
rules, in August 2000, the Department of Health and Human Services
(HHS) published a final rule on standards for electronic transactions
that established NDC numbers as the standard medical data code set for
reporting drugs and biologics in all standard transactions under HIPAA
(65 FR 50312). If a HIPAA-covered transaction includes a drug, the NDC
is required to be a part of the medical code data set (see 45 CFR
subpart J 162.1002(a)(3)). However, in the preamble to the HIPAA
regulations, HHS stated that it was adopting a uniform 11-digit format
to conform with customary practice used in computer systems (65 FR
50312 at 50329). The HIPAA standard 11-digit NDC format is standardized
such that the labeler code is always 5 digits, the product code is
always 4 digits, and the package code always 2 digits. To convert a 10-
digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to
the appropriate segment to create the 11-digit configuration as defined
above.
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    \1\ See http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html (last accessed July 3, 2017).
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    When FDA moves to a 6-digit labeler code, although these new 11-
digit native NDC \2\ configurations will have the same number of digits
as required by the HIPAA standards, they will not be in the same
format.\3\ Additionally, some of the systems that utilize HIPAA
standard 11-digit NDCs \4\ do not use hyphens to separate the segments
which, as illustrated below, will result in some 11-digit native NDCs
being indistinguishable from HIPAA standard 11-digit NDCs. Therefore,
to ensure unhyphenated NDCs are distinguishable, FDA anticipates that
the HIPAA standards, and other code sets that currently require 10-
digit native NDCs to be converted to 11-digit NDCs, will likely be
updated in some manner.
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    \2\ NDCs in the format and with the digits assigned by FDA are
referred to as native NDCs.
    \3\ An 11-digit native NDC will have an extra labeler code digit
but will be short a digit in either the product code or package
code.
    \4\ NDCs that contain additional digits necessary to comply with
HIPAA standards are referred to as Converted NDCs.

                                         Table 1--NDC Conversion Example
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                                                                         Converted NDC format
                                                     -----------------------------------------------------------
                  Native NDC format                        10-digit       11-digit converted  11-digit converted
                                                          hyphenated         (hyphenated)       (unhyphenated)
----------------------------------------------------------------------------------------------------------------
Native 10-digit (5-3-2).............................        10010-001-01       10010-0001-01<PHONE_NUMBER>1

Native 11-digit (6-3-2).............................  ..................       100100-001-01<PHONE_NUMBER>1
----------------------------------------------------------------------------------------------------------------

II. Purpose and Scope of the Hearing

    The purpose of this public hearing is to obtain and discuss
stakeholder feedback on the future format of NDCs. FDA is seeking
information on the following topics:
    1. The impact of transitioning from a 5-digit labeler code to a 6-
digit labeler code, including the business, economic, information
technology, and medical/clinical practice impacts, and its impact on
the safety and security of drug products.
    2. Issues associated with the current lack of NDC uniformity in the
marketplace.
    3. What should FDA consider as it explores any further changes or
expansion to the format or length of the NDC?
    4. How to best transition to a new format for the NDC.
    To facilitate stakeholder feedback, some options for discussion and
questions will be posted in the docket and on FDA's website at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm at least 30 days prior to
the hearing. These options and questions are not meant to be
exhaustive. We encourage interested stakeholders to address these and/
or other issues related to the formatting of NDCs. FDA encourages
stakeholders to provide the rationale and basis for their comments,
including any available data and information, and any underlying
assumptions. For example, to provide context associated with a
stakeholders response, FDA also is interested in the following
information within the submission or testimony.
    1. How would you describe your business or area of focus (e.g.,
payor, hospital, health care practitioner, benefit manager or
administrator, pharmacy, manufacturer, repackager, wholesale
distributor, third-party logistics provider, drug compendia, standard
setting organization, government entity)?
    2. How do you or your members use the NDC?
    3. What challenges does your organization or your members face with
the current NDC and how do you overcome these challenges?
    4. What changes, if any, would you or your members need to make to
your systems to accommodate the 6-digit labeler code or other larger
NDC formats?

III. Registration

Registration and Requests for Oral Presentations

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and early registration is recommended. Individuals who wish to
attend must register on or before October 15, 2018, at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and provide complete contact
information, including name, title, affiliation, email, and phone
number. Those without internet access may register by contacting Leyla
Rahjou-Esfandiary at<PHONE_NUMBER>. FDA may allow onsite registration if
space is available. If registration reaches maximum capacity, FDA will
post a notice closing registration at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm.
    This hearing will include public comment sessions. Individuals who
wish to present during a public comment session at the public hearing
must register as noted at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and identify the topics or questions (see section II)
they wish to address in their presentation and the stakeholder group
they best associate with, if any, to help FDA organize the
presentations. Individuals and organizations with common interests are
urged to consolidate or coordinate their presentations and request time
for a joint presentation.
    FDA will do its best to accommodate requests to present during the
public comment session and will determine the amount of time allotted
for each oral presentation and the approximate time that each oral
presentation is scheduled to begin. FDA will notify registered
presenters of their scheduled times and make available an agenda and
background material at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on or before October 22, 2018. Once FDA notifies
registered presenters of their scheduled times, presenters should
submit an electronic copy of their presentation to
[email protected] on or before October 29, 2018.
    If you need special accommodations because of a disability, please
send an email to [email protected] at least 7 days before
the hearing.

Streaming Webcast of the Public Hearing

    A link to the live webcast of this public hearing will be available
at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on the day of
public hearing. A video record of the public hearing will be available
at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm following the
hearing.

IV. Notice of Public Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the relevant centers/offices.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
At their discretion, the presiding officer(s) may permit questions to
be submitted from the audience for response by FDA or other persons
attending the hearing (Sec.  15.30(e)). Public hearings under part 15
are subject to FDA's policy and procedures for electronic media
coverage of FDA's public administrative proceedings (21 CFR part 10,
subpart C). Under Sec.  10.205, representatives of the electronic media
may be permitted, subject to certain limitations, to videotape, film,
or otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec.  15.30(b) (see Transcripts). To the extent that the

conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec.  15.30(h).

Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulation.gov. It may be viewed at
the Dockets Management Staff (see ADDRESSES). A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. The Freedom of Information office
address is available on the Agency's website at https://www.fda.gov.

    Dated: July 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16807 Filed 8-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Rules and Regulations]
[Pages 67288-67291]
[FR Doc No: 2020-22190]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0291; FRL-10012-67]

Diquat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of diquat
in or on pea and bean, dry and shelled, except soybean, subgroup 6C.
Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 22, 2020. Objections and
requests for hearings must be received on or before December 21, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0291, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0291 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 21, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0291, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 15, 2017 (82 FR 43354) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8571) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the herbicide diquat in or on
pea and bean, dry and shelled, except soybean, subgroup 6C at 0.08
parts per million (ppm). In the Federal Register of May 7, 2018 (83 FR
20008) (FRL-9976-34), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing a correction to the
pesticide petition (PP 7E8571) by Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The corrected petition requested that
40 CFR part 180 be amended by establishing tolerances for residues of
the herbicide diquat in or on pea and bean, dry and shelled, except
soybean, subgroup 6C at 0.9 parts per million (ppm). Both documents
referenced a summary of the petition prepared by Syngenta, the
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for diquat including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with diquat follows.
    EPA conducted a human health risk assessment to evaluate the safety
of the requested tolerances. See ``Diquat. Human Health Risk Assessment
for the Establishment of a Tolerance without U.S. Registration for
Residues in/on Crop Subgroup 6C Dried Shelled Pea and Bean (Except
Soybean)'' (July 21, 2020), which is available in the docket
established by this action, which is described under ADDRESSES. Locate
and click on the hyperlink for docket ID number EPA-HQ-OPP-2017-0291.
In that document, EPA evaluated the available hazard and exposure data
to conduct dietary, residential, and aggregate assessment to determine
risk to human health and refers back to the discussions of the hazard
profile, residue chemistry database, and residential exposures
contained in the previous human health risk assessment conducted for
registration review, ``Diquat Dibromide: Draft Human Health Risk
Assessment for Registration Review'' (Sept. 17, 2015) (``Registration
Review RA''), which can be found in the docket EPA-HQ-OPP-2009-0846 and
is included in this docket. Based on the discussion in the Registration
Review RA, the Agency has determined that there is reliable data to
support the use of a 1X margin of safety for the protection of infants
and children.
    While the acute dietary assessment was unrefined, using tolerance-
level residues and 100% crop treated (PCT), the chronic dietary
assessment was more refined and used anticipated-residue levels from
magnitude of residue studies for crops irrigated with water treated
with diquat in conjunction with estimates of percentage of crops
irrigated. Default processing factors were also used in both the acute
and chronic dietary analyses and both analyses incorporated the Office
of Water's Maximum Contaminant Level (0.02 ppm) as a worst-case
drinking water estimate due to domestic uses of diquat. EPA's aggregate
exposure assessment incorporated the total dietary exposure, as well as
exposure from residential sources, which is not impacted by the
tolerance without U.S. registrations on pea and bean, dry and shelled,
except soybean, subgroup 6C and thus has not changed since the
Registration Review RA.
    Acute aggregate dietary risks (food and water) are below the
Agency's level of concern of 100% of the acute population adjusted
dose: 1.4% of the aPAD for children 1 to 2 years old, the population
group receiving the greatest exposure. Chronic dietary risks are below
the Agency's level of concern of 100% of the chronic population
adjusted dose (cPAD): 41% of the cPAD for children 1 to 2 years old the
population group receiving the greatest exposure. For the short-/
intermediate-term aggregate risk assessment, potential residential
exposures were combined with dietary exposures. For both adults and
children 1 to <2, exposures from high-contact activities on outdoor
treated turf resulted in the highest residential exposures for
aggregate consideration. Short-/intermediate-term aggregate margins of
exposure (MOEs) are greater than the LOC of 100 (2,010 for adults and
280 for children 1 to 2 years old) and are therefore not of concern.
Due to the lack of carcinogenicity, the Agency concludes that exposure
is not expected to pose a cancer risk to the U.S. population.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to diquat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (analytical method number RAM 272/
02 ``The Determination of Residues of Paraquat and Diquat in crops and
Soil--A High Performance Liquid Chromatographic Method'') is available
to enforce the tolerance expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established an MRL for diquat in or on dry pea
(subgroup) at 0.9 ppm. This MRL is the same as the tolerance
established for diquat in this decision. However, Codex has established
MRLs for diquat in or on dry bean (subgroup) at 0.4 ppm. Canada has
established MRLs for both dry pea and dry bean at 0.9 ppm.

C. Response to Comments

    Two general comments were received on the notices of filing
expressing general concern about the potential of pesticide residues in
food, although none provided any substantive information to take into
consideration in EPA's safety assessment. The FFDCA authorizes EPA to
establish tolerances that permit certain levels of pesticide residues
in or on food when the Agency can determine that such residues are
safe. EPA has made that determination for the tolerances subject to
this action; commenters provided no information relevant to that
conclusion.

V. Conclusion

    Therefore, tolerances are established for residues of diquat in or
on pea and bean, dry and shelled, except soybean, subgroup 6C at 0.9
ppm and the tolerance expression is being updated.

    Also, in accordance with EPA's policy to update its tolerance
expressions where applicable, EPA is revising the tolerance expression
to clarify that (1) as provided in FFDCA section 408(a)(3), the
tolerance covers metabolites and degradates of diquat not specifically
mentioned; and (2) compliance with the specified tolerance levels is to
be determined by measuring only the specific compounds mentioned in the
tolerance expression. EPA has determined that it is reasonable to make
this change final without prior proposal and opportunity for comment
because public comment is not necessary since the change is merely
intended to clarify the existing tolerance expression and has no
substantive effect on the tolerance.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 16, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.226, amend paragraph (a)(1) by:
0
a. Revising the introductory text and adding a heading for the table;
and
0
b. Adding in alphabetical order to the table the entry for ``Pea and
bean, dry and shelled, except soybean, subgroup 6C'' and footnote 1.
    The revision and additions read as follows:

Sec.  180.226   Diquat; tolerances for residues.

    (a) * * *
    (1) Tolerances are established for the residues of the herbicide
diquat, including its metabolites and degradates, in or on the
commodities in Table 1 to this paragraph (a)(1) resulting from the
application of the dibromide salt of diquat. Compliance with the
tolerance levels specified in Table 1 to this paragraph (a)(1) is to be
determined by measuring only diquat (6,7-dihydrodipyrido[1,2-a:2',1'-
c]pyrazinediium):

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                     Commodity                        Parts per million
------------------------------------------------------------------------

                              * * * * * * *
Pea and bean, dry and shelled, except soybean,                      0.9
 subgroup 6C \1\..................................

                              * * * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities as of October
  22, 2020.

* * * * *
[FR Doc. 2020-22190 Filed 10-21-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6809-6811]
[FR Doc No: 2023-02050]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0246]

Parts and Accessories Necessary for Safe Operation; Exemption
Application From Polytech Plastic Molding, Inc

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

ACTION: Notice of application for exemption; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA)
requests public comment on Polytech Plastic Molding's (Polytech)
application for an exemption from the requirement that lighting devices
be steady burning. The exemption would allow the company to operate
commercial motor vehicles (CMVs) equipped with a module manufactured by
Intellistop, Inc. (Intellistop) which pulses the rear clearance,
identification, and brake lamps from low-level lighting intensity to
high-level lighting intensity 4 times in 2 seconds when the brakes are
applied. FMCSA requests public comment on the applicant's request for
exemption.

DATES: Comments must be received on or before March 3, 2023.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Number FMCSA-2022-0246 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Dockets Operations, 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, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Each submission must include the Agency name and the docket number
(FMCSA-2022-0246) for this notice. Note that DOT posts all comments
received without change to

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 www.regulations.gov at any time or visit 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., ET, Monday through Friday,
except Federal holidays. To be sure someone is there to help you,
please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting Dockets
Operations.
    Privacy Act: In accordance with 49 U.S.C. 31315(b), DOT solicits
comments from the public to better inform its exemption 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
https://www.transportation.gov/privacy, the comments are searchable by
the name of the submitter.

FOR FURTHER INFORMATION CONTACT: Mr. Jos[eacute] R. Cestero, Vehicle
and Roadside Operations Division, Office of Carrier, Driver, and
Vehicle Safety, FMCSA, at<PHONE_NUMBER>, or by email at
[email protected].
    If you have questions on viewing or submitting material to the
docket, contact Dockets Operations at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. 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-2022-0246), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. 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, go to www.regulations.gov and put
the docket number ``FMCSA-2022-0246'' in the keyword box, and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, click the ``Comment'' button, and type your
comment into the text box on 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.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant
exemptions from Federal Motor Carrier Safety Regulations (FMCSRs).
FMCSA must publish a notice of each exemption request in the Federal
Register (49 CFR 381.315(a)). The Agency must provide the public an
opportunity to inspect the information relevant to the application,
including any safety analyses that have been conducted. The Agency must
provide an opportunity for public comment on the request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The Agency must
publish its decision in the Federal Register (49 CFR 381.315(b)) with
the reasons for denying or granting the application and, if granted,
the name of the person or class of persons receiving the exemption and
the regulatory provision from which the exemption is granted. The
notice must specify the effective period and explain the terms and
conditions of the exemption. The exemption may be renewed (49 CFR
381.300(b)).

III. Polytech's Request

    Polytech seeks an exemption from the requirement in 49 CFR
393.25(e) that all exterior lamps (both required lamps and any
additional lamps) be steady-burning, except for turn signal lamps,
hazard warning signal lamps, school bus warning lamps, amber warning
lamps or flashing warning lamps on tow trucks and CMVs transporting
oversized loads, and warning lamps on emergency and service vehicles
authorized by State or local authorities.
    Polytech asserts that using the Intellistop module, which pulses
the rear clearance, identification, and brake lamps from low-level
lighting intensity to high-level lighting intensity 4 times in 2
seconds when the brakes are applied rather than providing steady
burning lamps during the first 2 seconds, would enhance rear signal
systems. Polytech submits that pulsing the rear brake lamps of a CMV
may significantly increase visibility and reduce the frequency of rear-
end crashes, and thus would maintain a level of safety that is
equivalent to, or greater than, the level that the CMV would achieve
without the requested exemption.
    On October 7, 2022 (87 FR 61133), FMCSA denied Intellistop's
application for an industry-wide exemption to allow all motor carriers
to operate commercial motor vehicles (CMVs) equipped with Intellistop's
module. FMCSA noted that the decision did not preclude individual motor
carriers from seeking an exemption from 49 CFR 393.25(e) to purchase,
install, and use Intellistop's device subject to terms and conditions
to allow sufficient monitoring of the use of the device. Therefore,
consistent with the October 7, 2022, decision, the Agency seeks public
comment on Polytech's carrier-specific exemption application.
    A copy of Polytech's application is included in the docket
referenced at the beginning of this notice.

IV. Request for Comments

    In accordance with 49 U.S.C. 31315(b), FMCSA requests public
comment from all interested persons on Polytech's application for a
five-year exemption from 49 CFR 393.25(e) to allow the company to
operate CMV's, including flatbed trailers and straight trucks, equipped
with Intellistop's module which pulses the rear clearance,
identification and brake lamps from low-level lighting intensity to
high-level lighting intensity 4 times in 2 seconds when the brakes are
applied.
    All comments received before the close of business on the comment
closing date will be considered and will be available for examination
in the docket at the location listed under the Addresses section of
this notice. Comments received after the comment closing date will be
filed in the public docket and may be considered to the extent
practicable. In addition to late comments, FMCSA will also continue to
file, in the public docket, relevant information that becomes available
after the comment closing date. Interested

persons should continue to examine the public docket for new material.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-02050 Filed 1-31-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Page 33807]
[FR Doc No: 2021-13484]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request for Land Use Change From
Aeronautical to Non-Aeronautical for 7.6 Acres of Land at Lebanon
Municipal Airport, Lebanon, NH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comments.

-----------------------------------------------------------------------

SUMMARY: Notice is being given that the FAA is considering a request
from the City of Lebanon, NH to change the land use from Aeronautical
to Non-Aeronautical use for 7.6 acres of land at Lebanon Municipal
Airport, Lebanon, NH. The land is not required for aeronautical use and
can be developed as an extension of the existing business park. The
expansion would create a new long term revenue source for the airport
and the proceeds will be deposited in the airport's operations and
maintenance account.

DATES: Comments must be received on or before July 26, 2021.

ADDRESSES: You may send comments using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, and follow the instructions on providing comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Interested persons may inspect the request and supporting documents
by contacting the FAA at the address listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Mr. Jorge E. Panteli, Compliance and
Land Use Specialist, Federal Aviation Administration New England Region
Airports Division, 1200 District Avenue, Burlington, Massachusetts
01803. Telephone:<PHONE_NUMBER>.

    Authority: 49 United States Code 47107(h)(2).

    Issued in Burlington, Massachusetts, on June 21, 2021.
Julie Seltsam-Wilps,
Deputy Director.
[FR Doc. 2021-13484 Filed 6-24-21; 8:45 am]
BILLING CODE P


[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Page 38371]
[FR Doc No: 2020-13809]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9051-5]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed June 15, 2020, 10 a.m. EST Through June 22, 2020, 10 a.m. EST
Pursuant to 40 CFR 1506.9.

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20200130, Final, USFS, OR, Flat Country, Review Period Ends:
08/10/2020, Contact: Dean Schlichting<PHONE_NUMBER>.
EIS No. 20200131, Draft, USACE, FL, Florida Keys Coastal Storm Risk
Management Report/Environmental Impact Statement, Comment Period Ends:
08/10/2020, Contact: Kathy Perdue<PHONE_NUMBER>.
EIS No. 20200132, Final, BR, CA, Auburn State Recreation Area
Preliminary General Plan and Auburn Project Lands Draft Resource
Management Plan Final Environmental Impact Report/Environmental Impact
Statement, Review Period Ends: 07/27/2020, Contact: Bonnie Van Pelt
916-537-7062.
EIS No. 20200133, Final, BLM, AK, National Petroleum Reserve in Alaska
Final Integrated Activity Plan and Environmental Impact Statement,
Review Period Ends: 07/27/2020, Contact: Stephanie Rice<PHONE_NUMBER>.

Amended Notice

EIS No. 20200111, Draft, CHSRA, CA, Burbank to Los Angeles Project
Section Draft Environmental Impact Report/Environmental Impact
Statement, Comment Period Ends: 07/31/2020, Contact: Dan McKell 916-
330-5668.

    Revision to FR Notice Published 5/29/2020; Extending the Comment
Period from 7/13/2020 to 7/31/2020.

    Dated: June 23, 2020.
Candi Schaedle,
Acting Director, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2020-13809 Filed 6-25-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Page 24593]
[FR Doc No: 2016-09665]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1462-000]

Palmco Power DE LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Palmco Power DE LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 10, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: April 20, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-09665 Filed 4-25-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Notices]
[Pages 34802-34803]
[FR Doc No: 2011-14731]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2005-21613]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 of the Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated April 26, 2011, and an amending document dated May 3,
2011, the Association of American Railroads (AAR) has petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR Part 229. FRA assigned the petition Docket Number FRA-2005-
21613.
    FRA granted an extension of waiver Docket Number FRA-2005-21613 to
AAR on May 3, 2011, continuing an extensive testing and inspection
program to determine extended clean, repair and test intervals for air
brake valves and related components as required by the Railroad
Locomotive Safety Standards at 49 CFR 229.27 Annual tests and 229.29
Biannual tests. Fourteen (14) separate groups of locomotives were
identified for investigation in the waiver approval letter. Among the
variables between groups are the model of electronic airbrake system
used on the locomotives and whether the group of locomotives was
manufactured by General Electric (GE) or ElectroMotive Diesel (EMD).
AAR has now submitted additional requests for modification of this
waiver. The first request is to add locomotives equipped with New York
Air Brake (NYAB) CCB-26 model brake systems in the same group as
locomotives equipped with CCB-II brake systems. Also, AAR has requested
that the distinction between locomotive manufacturers be

dropped, thus reducing the number of groups to be tested.
    In support of this petition, AAR submitted supporting documentation
from NYAB attesting to the essential similarity of the CCB-26 brake
system to the CCB-II brake system already covered under the waiver. In
addition, AAR states that testing performed to date under this waiver
has allayed concerns that air brake system performance would vary
between EMD and GE locomotives.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at http://www.regulations.gov and in person at the Department of Transportation's
Docket Operations Facility, 1200 New Jersey Ave., SE., W12-140,
Washington, DC 20590. The Docket Operations Facility is open from 9
a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by July 29, 2011will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78) or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC on June 9, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory & Legislative Operations.
[FR Doc. 2011-14731 Filed 6-13-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Rules and Regulations]
[Pages 36131-36134]
[FR Doc No: 2012-14634]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0562; Directorate Identifier 2012-SW-038-AD;
Amendment 39-17068; AD 2012-11-05]
RIN 2120-AA64

Airworthiness Directives; Enstrom Helicopter Corporation
Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

-----------------------------------------------------------------------

SUMMARY: We are superseding an existing airworthiness directive (AD)
for Enstrom Helicopter Corporation (Enstrom) Model F-28C, F-28C-2, F-
28F, 280C, 280F, 280FX, TH-28, 480, and 480B helicopters to add another
trim relay to the applicability and to revise the modification
instructions. This AD is prompted by the discovery that another part-
numbered trim relay, inadvertently omitted from the current AD, may
contain the same unsafe condition. These actions are intended to
prevent failure of the cyclic trim system and subsequent loss of
control of the helicopter.

DATES: This AD becomes effective July 3, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 3,
2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
January 23, 2012 (77 FR 729, January 6, 2012).
    We must receive comments on this AD by August 17, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200

New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket: You may examine the AD docket on the Internet
at http://www.regulations.gov or in person at the Docket Operations
Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the economic evaluation, any
comments received, and other information. The street address for the
Docket Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this AD, contact Enstrom
Helicopter Corporation, 2209 22nd St., Menominee, Michigan, 49858-0490;
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Web site: http://www.enstromhelicopter.com/enstrom_new/enstrom_support_tec.html. You may review a copy of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Gregory J. Michalik, Enstrom Program
Manager, FAA, Chicago Aircraft Certification Office, 2300 East Devon
Avenue, Room 107, Des Plaines, Illinois, 60018; telephone (847) 294-
7135; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    On December 14, 2011, we issued AD 2011-26-10, amendment 39-16900
(77 FR 729, January 6, 2012) for Enstrom Model F-28C, F-28C-2, F-28F,
280C, 280F, 280FX, TH-28, 480, and 480B helicopters with a trim relay,
part-number (P/N) KUP14D55-472, M83536/10-015M, or M83536/10-024M. That
AD requires modifying the lateral and longitudinal trim actuator
assemblies by replacing the actuator and limit switch bracket to
provide a positive stop for the trim actuator. In the event of a trim
actuator runaway, the new bracket will stop the actuator, causing the
circuit breaker to trip before any significant loss of control occurs.
After the trim actuator assemblies are modified, that AD requires
performing operational (ground) and flight tests to determine that the
trim relay is working correctly. That AD was prompted by reports of 4
failures in the cyclic trim system in the field, 2 that occurred on the
Enstrom Model 480B helicopter and 2 that occurred on the Enstrom Model
F28 helicopter. These failures resulted in reduced controllability of
the helicopter. We issued that AD to prevent failure of the cyclic trim
system and subsequent loss of control of the helicopter.

Comments

    Since we issued immediately adopted AD 2011-26-10, we received one
comment from Enstrom, the manufacturer, and Revision 4 to Enstrom
Service Directive Bulletin No. 0110, dated January 23, 2012 (SDB 0110),
for Model F-28C, F-28C-2, F-28F, 280C, 280F, and 280FX helicopters. In
its comment, the manufacturer stated that the list of affected part
numbers for the F-28 series and 280 series helicopter should include P/
N KUP14D55-24 and that this P/N was erroneously left off of Enstrom's
original Service Directive Bulletin. It stated that the same safety
concerns also exist with this relay and that adding this P/N will not
affect the cost analysis or fleet size as these aircraft were included
in the initial calculations.
    We agree with the commenter that the additional part numbered relay
contained in Enstrom SDB 0110 should be added to the applicability
section of the AD because it may contain the same unsafe condition.
Also, we agree that the revised compliance instructions contained in
SDB 0110 should be required.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information, including the comment received and the revised service
information, and determined the unsafe condition described previously
is likely to exist or develop in other helicopters of these same type
designs.

Related Service Information

    We reviewed Enstrom SDB No. T-039, Revision 3, dated July 6, 2011
(SDB T-039), for Model TH-28, 480, and 480B helicopters and Enstrom SDB
0110, for Model F-28C, F-28C-2, F-28F, 280C, 280F, and 280FX
helicopters. SDB T-039 specifies, for helicopters with a trim relay, P/
N M83536/10-024M, procedures for modifying the lateral and longitudinal
trim actuator assembly using the cyclic trim assembly kit (modification
kit), P/N 4230045-1, and specifies performing an operational check and
flight test to determine if the trim is operating correctly after the
modification. SDB 0110 specifies, for helicopters with a trim relay, P/
N KUP14D55-24, KUP14D55-472, M83536/10-015M, or M83536/10-024M,
procedures for modifying the lateral and longitudinal trim actuator
assembly using the modification kit, P/N 28-01063-1, and specifies
performing an operational check and flight test to determine if the
trim is operating correctly after the modification. The SDBs state that
the modification kits contain the upgraded bracket.

AD Requirements

    In addition to those part-numbered trim relays contained in the
applicability section of the current AD 2011-26-10, this AD adds trim
relay P/N KUP14D55-24. Also, this AD adopts the revised modification
instructions for the Model F-28C, F-28C-2, F-28F, 280C, 280F, and 280FX
helicopters contained in SDB 0110. Otherwise, this AD retains most of
the requirements of AD 2011-26-10, which requires modifying the lateral
and longitudinal trim actuator assembly, using modification kit, P/N
28-01063-1, for the Model F-28C, F-28C-2, F-28F, 280C, 280F, and 280FX
helicopters and modification kit, P/N 4230045-1, for the Model TH-28,
480, and 480B helicopters, and verifying that the modification has been
completed properly by performing an operational and flight test after
the modification is complete.
    The actions required by this AD are to be accomplished by following
specified

portions of the SDBs described previously.

Differences Between This AD and the Service Information

    The SDBs specify, before further flight, to insert a special
addendum into the Emergency Procedures section of the Flight Manual,
and this AD does not require this action.

Costs of Compliance

    We estimate that this AD will affect 207 helicopters of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD. For Model 480, 480B, and TH-28, modifying
the actuator assemblies will require 8 work hours at a cost of $85 per
hour and parts will cost $327; the cost per helicopter will be $1,007.
For Model 280C, 280F, 280FX, F-28C, F-28C-2, and F-28F, modifying the
actuator assemblies will require 8 work hours at a cost of $85 per
hour; parts will cost $383; and the cost per helicopter will be $1,063.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the required corrective
actions must be accomplished within 5 hours time-in-service, a very
short time period based on the average flight-hour utilization rate of
these helicopters.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and contrary to
the public interest and that good cause exists for making this
amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-16900 (77 FR
729, January 6, 2012), and adding the following new airworthiness
directive (AD):

2012-11-05 Enstrom Helicopter Corporation: Amendment 39-17068;
Docket No. FAA-2012-0562; Directorate Identifier 2012-SW-038-AD.

(a) Applicability

    This AD applies to the Enstrom Model F-28C, F-28C-2, F-28F,
280C, 280F, 280FX, TH-28, 480, and 480B helicopters with a trim
relay, part-number (P/N) KUP14D55-24, KUP14D55-472, M83536/10-015M,
or M83536/10-024M, certificated in any category.
    Note to paragraph (a) of this AD: This AD does not apply to the
specified helicopters with a reversible trim motor, P/N 28-16621
(Ford Motor Company C1AZ-14553A) or P/N AD1R-10 (Signal Electric).

(b) Unsafe Condition

    This AD defines the unsafe condition as a failure of a trim
relay in the cyclic trim system. This condition could result in
reduced controllability of the helicopter and subsequent loss of
control of the helicopter.

(c) Other Affected ADs

    This AD supersedes AD 2011-26-10, Amendment 39-16900 (77 FR 729,
January 6, 2012).

(d) Effective Date

    This AD becomes effective July 3, 2012.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    Within 5 hours time-in-service (TIS) or at the next annual or
100 hour TIS inspection, whichever occurs first:
    (1) For the Enstrom Model F-28C, F-28C-2, F-28F, 280C, 280F, and
280FX helicopters, modify the lateral and longitudinal trim actuator
assemblies using the cyclic trim assembly kit (modification kit), P/
N 28-01063-1, in accordance with the instructions in paragraph 6.1
of the Enstrom Service Directive Bulletin (SDB) No. 0110, Revision
4, dated January 23, 2012 (SDB No. 0110 R4), except when the
instructions specify using ``Aeroshell 22 grease'' or ``VC-3 Vibra-
tite thread locker,'' you may use an equivalent product.
    (2) For the Enstrom Model TH-28, 480, and 480B helicopters,
modify the lateral and longitudinal trim actuator assemblies using
the modification kit, P/N 4230045-1, in accordance with the
instructions in paragraph 6.1 of the Enstrom SDB No. T-039, Revision
3, dated July 6, 2011 (SDB No. T-039 R3), except when the
instructions specify using ``Aeroshell 22 grease'' or ``VC-3 Vibra-
tite thread locker,'' you may use an equivalent product, and you are
not required to contact Enstrom Customer Service.
    (3) After modifying the lateral and longitudinal trim actuator
assemblies in accordance with paragraphs (f)(1) or (f)(2) of this
AD, before further flight, operationally test the trim limits in
accordance with paragraph 6.2. of the SDB for your model helicopter,
and determine during a flight test whether there is appropriate trim
authority in accordance with paragraph 6.3. of the SDB for your
model helicopter.

(g) Special Flight Permits

    A one-time special-flight permit may be issued in accordance
with 14 CFR 21.197 and 21.199 provided the helicopter is operated
with the trim system circuit breaker pulled.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Gregory J.
Michalik, Enstrom Program Manager, FAA, Chicago Aircraft
Certification Office, 2300 East Devon Avenue, Room 107, Des Plaines,
Illinois, 60018; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6710: Main Rotor
Control.

 (j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the following service
information under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
July 3, 2012.
    (i) Enstrom Service Directive Bulletin No. 0110, Revision 4,
dated January 23, 2012, for Model F-28C, F-28C-2, F-28F, 280C, 280F,
and 280FX helicopters.
    (4) The following service information was approved for IBR on
January 23, 2012 (77 FR 729, January 6, 2012).
    (i) Enstrom Service Directive Bulletin No. T-039, Revision 3,
dated July 6, 2011, for Model TH-28, 480, and 480B helicopters.
    (5) For service information identified in this AD, contact
Enstrom Helicopter Corporation, 2209 22nd St., Menominee, Michigan,
49858-0490; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Web site: http://www.enstromhelicopter.com/enstrom_new/enstrom_support_tec.html.
    (6) You may review a copy of the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 2601
Meacham Blvd., Room 663, Fort Worth, Texas 76137 or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Fort Worth, Texas, on May 17, 2012.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-14634 Filed 6-15-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15436-15438]
[FR Doc No: 2022-05782]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1517]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Abbreviated New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of abbreviated new animal drug applications.

DATES: Submit either electronic or written comments on the collection
of information by May 17, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1517 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Abbreviated New Animal Drug
Applications.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))

OMB Control Number 0910-0669--Extension

    Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), any person may file an abbreviated new animal drug
application (ANADA) seeking approval of a generic copy of an approved
new animal drug. The information required to be submitted as part of an
ANADA is described in section 512(n)(1) of the FD&C Act. Among other
things, an ANADA is required to contain information to show that the
proposed generic drug is bioequivalent to, and has the same labeling
as, the approved new animal drug. We allow applicants to submit a
complete ANADA or to submit information in support of an ANADA for
phased review. Applicants may submit Form FDA 356v with a complete
ANADA or a phased review submission to ensure efficient and accurate
processing of information. Form FDA 356v is approved under OMB control
number 0910-0032. We use the information submitted, among other things,
to assess bioequivalence to the originally approved drug and thus, the
safety and effectiveness of the generic new animal drug.
    The information collection also includes applicant requests to
waive the requirement to establish bioequivalence through in vivo
studies (biowaiver requests) for soluble powder oral dosage form
products or certain Type A medicated articles based upon either of two
methods. We use the information submitted by applicants in the
biowaiver request as the basis for our decision whether to grant the
request. Therefore, the information collection references the guidance
document GFI #171--Demonstrating Bioequivalence for Soluble Powder Oral
Dosage Form Products and Type A Medicated Articles Containing Active
Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media,
which discusses statutory bioequivalence requirements as well as
qualifications for requesting a waiver from the requirements. The
guidance can be viewed on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated.
    The reporting associated with ANADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(2) of the FD&C Act. We use the information submitted,
among other things, to assess bioequivalence to the originally approved
drug and thus, the safety and effectiveness of the generic new animal
drug.
    Description of Respondents: The respondents for this collection of
information are veterinary pharmaceutical manufacturers.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average
                           Activity                             FDA Form No.      Number of     responses per   Total  annual    burden per      Total
                                                                                respondents     respondent       responses       response       hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA........................................................            356v              20               1              20             159      3,180
Phased review with administrative ANADA......................            356v               6               5              30            31.8        954
Biowaiver request for soluble powder oral dosage form                     N/A               1               1               1               5          5
 product, using same formulation/manufacturing process
 approach....................................................
Biowaiver request for soluble powder oral dosage form                     N/A               5               1               5              10         50
 product, using same API/solubility approach.................
Biowaiver request for Type A medicated article, using same                N/A               2               1               2               5         10
 formulation/manufacturing process approach..................
Biowaiver request for Type A medicated article, using same                N/A               5               1               5              20        100
 API/solubility approach.....................................
                                                              ------------------------------------------------------------------------------------------
    Total....................................................  ..............  ..............  ..............              63  ..............      4,299
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our records of generic animal drug
applications. We estimate that we will receive 26 ANADA submissions per
year over the next 3 years and that 6 of those submissions will request
phased review. We estimate that each applicant that uses the phased
review process will have approximately five phased reviews per
application. We estimate that an applicant will take approximately 159
hours to prepare either an ANADA or the estimated five ANADA phased
review submissions and the administrative ANADA. Our estimates of the
burden of biowaiver requests for generic soluble powder oral dosage
form products and Type A medicated articles differ based on the type of
product and the basis for the request, as shown in table 1. We estimate
that an applicant will take between 5 and 20 hours to prepare a
biowaiver request.
    Our estimated burden for the information collection reflects an
overall increase of 695 hours and a corresponding increase of 12
responses. Based on a review of the information collection since our
last request for OMB renewal, the increase in the burden hours estimate
is attributable to an increase in the number of respondents submitting
generic drug applications.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05782 Filed 3-17-22; 8:45 am]
BILLING CODE 4164-01-P