[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24718-24720]
[FR Doc No: 2017-11009]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2010-N-0258]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Petitions: Food Additive, Color Additive
(Including Labeling), Submission of Information to a Master File in
Support of Petitions; and Electronic Submission Using Food and Drug
Administration Form 3503

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the 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 FDA's regulations for submission
of petitions, including food and color additive petitions (FAPs and
CAPs) (including labeling) submission of information to a master file
in support of petitions, and electronic submission using FDA Form 3503.

DATES: Submit either electronic or written comments on the collection
of information by July 31, 2017. Late, untimely filed comments will not
be considered. Electronic comments must be submitted on or before July
31, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of July 31,
2017. 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.

ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0258 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Submission of Petitions: Food
Additive, Color Additive (Including Labeling); Submission of
Information to a Master File in Support of Petitions; Electronic
Submission Using Food and Drug Administration Form 3503.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>301-796-
7726.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Submission of Petitions: Food Additive, Color Additive (Including
Labeling); Submission of Information to a Master File in Support of
Petitions; Electronic Submission Using FDA Form 3503--21 CFR 70.25,
71.1, 171.1, 172, 173, 179, and 180; OMB Control Number 0910-0016--
Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be
deemed to be unsafe, unless: (1) The additive and its use, or intended
use, are in conformity with a regulation issued under Sec.  409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under Sec.  409(h) is effective. FAPs are
submitted by individuals or companies to obtain approval of a new food
additive or to amend the conditions of use permitted under an existing
food additive regulation. Section 171.1 of FDA's regulations (21 CFR
171.1) specifies the information that a petitioner must submit in order
to establish that the proposed use of a food additive is safe and to
secure the publication of a food additive regulation describing the
conditions under which the additive may be safely used. Parts 172, 173,
179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling
requirements for certain food additives to ensure their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under Sec.  721(f). CAPs are submitted by individuals or companies to
obtain approval of a new color additive or a change in the conditions
of use permitted for a color additive that is already approved. Section
71.1 of the Agency's regulations (21 CFR 71.1) specifies the
information that a petitioner must submit to establish the safety of a
color additive and to secure the issuance of a regulation permitting
its use. FDA's color additive labeling requirements in Sec.  70.25 (21
CFR 70.25) require that color additives that are to be used in food,
drugs, devices, or cosmetics be labeled with sufficient information to
ensure their safe use.
    FDA scientific personnel reviews FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
    Interested persons may transmit FAP or CAP regulatory submissions
in electronic format or paper format to the Office of Food Additive
Safety in the Center for Food Safety and Applied Nutrition using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete FDA Form 3503 will
continue to be 1 hour.
    Description of respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                 21 CFR section/FDA form                    respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Color Additive Petitions
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70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                 Food Additive Petitions
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171.1...................................................               3               1               3           7,093          21,279               0
FDA Form 3503...........................................               6               1               6               1               6               0
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...............................................  ..............  ..............  ..............  ..............          23,959          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    The estimate of burden for food additive or color additive
petitions is based on FDA's experience with the petition process. The
burden for this information collection has changed since the last OMB
approval because the Generally Recognized as Safe affirmations have
been removed pursuant to the implementation of ``Substances Generally
Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR
parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior
estimate of the number of petitions received because the average number
of petitions received annually has varied little over the past 10
years. The figures for hours per response are based on estimates from
experienced persons in the Agency and in industry. Although the
estimated hour burden varies with the type of petition submitted, an
average petition involves analytical work and appropriate toxicological
studies, as well as the work of drafting the petition itself. The
burden varies depending on the complexity of the petition, including
the amount and types of data needed for scientific analysis.
    Color additives are subjected to payment of fees for the
petitioning process. The listing fee for a color additive petition
ranges from $1,600 to $3,000, depending on the intended use of the
color additive and the scope of the requested amendment. A complete
schedule of fees is set forth in Sec.  70.19. An average of one
Category A and one Category B color additive petition is expected per
year. The maximum color additive petition fee for a Category A petition
is $2,600 and the maximum color additive petition fee for a Category B
petition is $3,000. Because an average of 2 CAPs are expected per
calendar year, the estimated total annual cost burden to petitioners
for this startup cost would be less than or equal to $5,600 ((1 x
$2,600) + (1 x $3,000) listing fees = $5,600). There are no capital
costs associated with CAPs. The labeling requirements for food and
color additives were designed to specify the minimum information needed
for labeling in order that food and color manufacturers may comply with
all applicable provisions of the FD&C Act and other specific labeling
acts administered by FDA. Label information does not require any
additional information gathering beyond what is already required to
assure conformance with all specifications and limitations in any given
food or color additive regulation. Label information does not have any
specific recordkeeping requirements unique to preparing the label.
Therefore, because labeling requirements under Sec.  70.25 for a
particular color additive involve information required as part of the
CAP safety review process, the estimate for number of respondents is
the same for Sec.  70.25 and Sec.  71.1, and the burden hours for
labeling are included in the estimate for Sec.  71.1. Also, because
labeling requirements under parts 172, 173, 179, and 180 for particular
food additives involve information required as part of the FAP safety
review process under Sec.  171.1, the burden hours for labeling are
included in the estimate for Sec.  171.1.

    Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11009 Filed 5-26-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 171 (Tuesday, September 6, 2022)]
[Notices]
[Pages 54487-54488]
[FR Doc No: 2022-19135]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG22-212-000.
    Applicants: Sun Valley Solar LLC.
    Description: Sun Valley Solar LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5021.
    Comment Date: 5 p.m. ET 9/20/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL22-17-000.
    Applicants: National Grid, Niagara Mohawk Power Corporation.
    Description: Niagara Mohawk Power Corporation d/b/a National Grid
submits Filing to Comply with Condition in March 11, 2022 Order and
Request for Commission Order Within 45 Days for the Smart Path Connect
Project.
    Filed Date: 8/23/22.
    Accession Number: 20220823-5102.
    Comment Date: 5 p.m. ET 9/7/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER20-1992-003.
    Applicants: Public Service Company of New Mexico.
    Description: Compliance filing: PNM Compliance Filing with July 1,
2022 Order to be effective 1/27/2020.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5099.
    Comment Date: 5 p.m. ET 9/20/22.

    Docket Numbers: ER20-2101-000.
    Applicants: Fern Solar LLC.
    Description: Amendment to July 26, 2022 Notice of Change in Status
of Fern Solar LLC.
    Filed Date: 8/24/22.
    Accession Number: 20220824-5085.
    Comment Date: 5 p.m. ET 9/14/22.

    Docket Numbers: ER21-955-003.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2022-08-30 Petition for Limited
Tariff Waiver to be effective N/A.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5051.
    Comment Date: 5 p.m. ET 9/20/22.

    Docket Numbers: ER22-1846-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: Deficiency Response--Waiver of Base
Plan Allocation Methodology to be effective 8/1/2022.
    Filed Date: 8/29/22.
    Accession Number: 20220829-5151.
    Comment Date: 5 p.m. ET 9/19/22.

    Docket Numbers: ER22-2742-000.
    Applicants: Rolling Hills Generating, L.L.C.
    Description: Rolling Hills Generating, LLC Submits Request for
Limited Waiver of Procedural Deadline.
    Filed Date: 8/26/22.
    Accession Number: 20220826-5226.
    Comment Date: 5 p.m. ET 9/16/22.

    Docket Numbers: ER22-2743-000.
    Applicants: Southwest Power Pool, Inc.

    Description: Sec.  205(d) Rate Filing: 4005 Mountrail-Williams
Electric & Lower Yellowstone Int Agr to be effective 12/31/9998.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5004.
    Comment Date: 5 p.m. ET 9/20/22.

    Docket Numbers: ER22-2744-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1276R28 Evergy Metro NITSA
NOA to be effective 9/1/2022.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5015.
    Comment Date: 5 p.m. ET 9/20/22.

    Docket Numbers: ER22-2745-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 6576; Queue No. AD2-062 to be effective 8/1/2022.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5052.
    Comment Date: 5 p.m. ET 9/20/22.

    Docket Numbers: ER22-2746-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2022-08-30 SPS Transmission
Modification to be effective 5/19/2021.
    Filed Date: 8/30/22.
    Accession Number: 20220830-5058.
    Comment Date: 5 p.m. ET 9/20/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 30, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-19135 Filed 9-2-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 123 (Monday, June 27, 2011)]
[Proposed Rules]
[Page 37300]
[FR Doc No: 2011-15868]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-0973; FRL-9319-3]

Approval and Promulgation of Air Quality Implementation Plans;
Illinois; Royal Fiberglass Pools, Inc. Adjusted Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve into the Illinois State
Implementation Plan (SIP) an adjusted standard for Royal Fiberglass
Pools (``Royal'') at its Dix, Illinois facility. On November 8, 2010,
the Illinois Environmental Protection Agency (IEPA) submitted to EPA
for approval an adjustment to the general rule, Use of Organic Material
Rule, commonly known as the eight pound per hour (8 lb/hr) rule, as it
applies to emissions of volatile organic matter (VOM) from Royal's pool
manufacturing facility. The adjusted standard relieves Royal from being
subject to the general rule for VOM emissions from its Dix facility.
EPA is approving this SIP revision because it will not interfere with
attainment or maintenance of the ozone National Ambient Air Quality
Standard (NAAQS).

DATES: Comments must be received on or before July 27, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2010-0545, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Please see the direct final rule which is located in the Final
Rules section of this Federal Register for detailed instructions on how
to submit comments.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the state's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: June 3, 2011.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2011-15868 Filed 6-24-11; 8:45 am]
BILLING CODE 6560-50-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDES

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

DATE:  		30-SEP-2008

SUBJECT:		4-(4-chloro-2-methylphenoxy)butanoic acid (MCPB);  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Proposed Section 3 Registration Action on Mint.

PC Code:  019201	DP Barcode:  350511

Decision No.:  383254	Registration No.:  71368-5

Petition No.:  7E7257	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  2365

TXR No.:  NA	CAS No.:  94-81-5

MRID No.:  NA	40 CFR: 180.318

FROM:		Sarah J. Levy, Chemist

Registration Action Branch 1 (RAB1)

Health Effects Division (HED; 7509P)

THROUGH:		Doug Dotson, Ph.D., Chemist

Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED (7509P)

and

George F. Kramer, Ph.D., Senior Chemist

RAB1/HED (7509P)

TO:			Sarah J. Levy, Risk Assessor

	RAB1/HED (7509P)

and

			Daniel Rosenblatt, Risk Manager (Team 05)

Registration Division (RD; 7505P)

Executive Summary

DEEM-FCID™), Version 2.03 which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support a Section 3 use request on mint.  A cancer dietary assessment was not conducted because MCPB was classified as not likely to be carcinogenic to humans.

Acute and Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

Tolerance-level residues and 100 percent crop treated (%CT) data were used in the acute and chronic dietary assessments.  For both acute and chronic dietary assessments, all population subgroups have risk estimates that are below HED's level of concern.  For the acute assessment, the most highly exposed population subgroup is all infants (<1 year old; 5.4% of the aPAD (acute population-adjusted dose)).  For the chronic assessment, the most highly exposed population subgroup is also all infants (<1 year old; 22% of the cPAD (chronic population-adjusted dose)).  The use of anticipated residues (ARs), empirical processing factors, and % crop treated (CT) would refine further HED’s exposure and risk estimates; however, refinement is not needed at this time.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for MCPB was conducted by F. Fort for purposes of the Reregistration Eligibility Decision (RED) (04-AUG-2005; DP#: 314047).  This document serves as an update to the last dietary assessment for the RED in which the proposed new use, mint, is included.

II.	Residue Information

Interregional Research Project No. 4 (IR-4), on behalf of the Agricultural Experiment Station of Washington, has submitted a petition, PP#7E7257, proposing the establishment of a permanent tolerance for residues of the herbicide MCPB in/on mint tops (leaves and stems).  The residue chemistry data were reviewed in conjunction with this petition on 30-SEP-2008 (Memo, S. Levy, DP#: 349646).  HED is recommending in favor for a tolerance of 0.20 ppm (Table 2, below).

MCPB is a selective herbicide used postemergence as a broadcast foliar application to control broad-leaved annual and perennial weeds (Canada thistle).  The end-use products are sodium salts; the only registered food use is on peas (40 CFR §180.318).  There are no livestock feedstuffs associated with the registered or proposed uses on pea or mint, respectively.  MCPB is a List B chemical.  HED’s chapter for the MCPB RED document was issued in 2005 (Memo, E. Méndez, 04-AUG-2005; DP#: 314047).

For purposes of this petition, based on the pea foliage metabolism data and since mint is a minor crop (low-consumption commodity), the nature of the residue in primary crops is adequately understood based on a metabolism study conducted with peas.  The HED Metabolism Committee determined that the residues to be regulated for both tolerance and risk assessment purposes in plant commodities are the free and conjugated MCPB and MCPA ((4-chloro-2-methylphenoxy) acetic acid) (08-JUN-1995).  Note that the current tolerance established under 40 CFR §180.318 is for residues of MCPB per se in/on peas at 0.1 ppm.  The tolerance expression should be revised in accordance with HED recommendations (the HED Metabolism Committee decision and the HED Chapter of the RED) to include both free and conjugated MCPB and MCPA for plant commodities.  Also, HED notes that the preferred chemical names for MCPB and MCPA are 4-(4-chloro-2-methylphenoxy)butanoic acid and (4-chloro-2-methylphenoxy)acetic acid, respectively.  Table 1 is a summary of the residues of concern.

Table 1.  Residues of Concern in Crops, Livestock, and Drinking Water.

Matrix	Tolerance Expression	Residues for Risk Assessment

Pea and mint	free and conjugated MCPB and MCPA	free and conjugated MCPB and MCPA

Livestock	NA for purposes of this petition 	NA for purposes of this petition

Drinking Water	NA	MCPB and MCPA

Residue Data used for the Acute and Chronic Assessment:

Tolerance-level residues and 100%CT data were used in the acute and chronic dietary assessments.  The use of ARs, empirical processing factors, and %CT data would refine further HED’s exposure and risk estimates.  However, refinements of the dietary exposure estimates are not needed at this time.  See Table 2 for a summary of the data used in the acute and chronic assessments.

Table 2.  Data and Residue Estimates Used in the Acute and Chronic Dietary Analyses.1

RAC	Data Source	Existing Tolerance (ppm)

HED-Recommended Tolerance Level

(ppm)

Mint	DP#: 349646	--	0.20

		            1  100% CT was assumed for all commodities.

    Drinking Water Data

The drinking water residues used in the dietary risk assessments were provided by the Environmental Fate and Effects Division (EFED) in a memorandum by J. Lin (27-FEB-2008; DP#: 343745) and incorporated directly into this dietary assessment.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”  The estimated drinking water concentration (EDWC) values for mint were less than the values calculated for peas; therefore, the EDWC values for peas were used as the representative drinking water concentrations (Memo, K. Costello, 03-AUG-2005; DP#: 314053).  Both monitoring analysis and modeling approach were applied in the pea assessment.  A summary of the model estimates for drinking water from both surface water and groundwater sources is shown below.  Surface water estimates were used in acute and chronic food and water dietary exposure assessments.  For purposes of this assessment, the highest (i.e., most conservative) values were used for the acute (54.7 ppb) and chronic (13.5 ppb) assessments.  The models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/ models/water/.

	Surface water (PRZM/EXAMS)

Acute (peak)				54.7 µg/L

Chronic (annual average)		13.5 µg/L

Cancer (30-year average)		7.3 µg/L

Groundwater (SCI-GROW)			2.1 µg/L

IV.	DEEM-FCID™ Program and Consumption Information

MCPB acute and chronic dietary exposure assessments were conducted using the DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups:  the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

The toxicological endpoints used in this assessment are summarized below in Table 3 (HED Chapter of the RED Document, E. Méndez, 04-AUG-2005; DP#: 314047).  The MCPB risk assessment team re-evaluated the endpoints selected previously.

Table 3.  Summary of Toxicological Doses and Endpoints for MCPB for Use in Dietary Human Risk Assessments.

Exposure

Scenario

Point of Departure

Uncertainty/

FQPA Safety Factors

RfD, PAD, Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary (general population including females 13-49 years old) NOAEL = 200 mg/kg/day	UFA = 10x

UFH = 10x

UFDB = 10x

FQPA SF = 10x	Acute RfD = 0.2 mg/kg/day

aPAD = 0.2 mg/kg/day	Acute neurotoxicity (MCPA, rat).  LOAEL = 400 mg/kg/day based on gait impairment in males.

Chronic Dietary (all populations)

NOAEL = 4.4 mg/kg/day

 	UFA = 10x

UFH = 10x

UFDB = 10x

FQPA SF = 10x	Chronic RfD = 0.0044 mg/kg/day

cPAD = 0.0044 mg/kg/day	Chronic toxicity (MCPA, rat).  LOAEL = 17.6 mg/kg/day based on liver and kidney toxicity.

Cancer (oral)

Classification:  Not Likely to be carcinogenic to humans.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no-observed adverse-effect level.  LOAEL = lowest-observed adverse-effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  UFDB= incomplete database.  FQPA SF = FQPA Safety Factor.  PAD = population-adjusted dose (a = acute, c = chronic).  RfD = reference dose.

VI.	Results/Discussion/Conclusions

The DEEM-FCID™ analysis estimates the dietary exposure of the U.S. population and various population subgroups.  The results for the acute and chronic assessments reported in Table 4 are for the U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, males 20-49, and adults 50+ years.  A cancer dietary assessment was not conducted because MCPB was classified as not likely to be carcinogenic to humans.

The acute and chronic dietary exposure assessments (using tolerance level residues and 100% CT information for all registered and proposed uses) were conducted for the general U.S. population and various population subgroups.  Drinking water values were incorporated directly into the acute and chronic dietary assessments.  These assessments conclude that the acute and chronic dietary exposure estimates are not of concern to HED for the general U.S. population or any population subgroup.  For the acute assessment, the most highly exposed population subgroup is all infants (<1 year old; 5.4% of the aPAD).  For the chronic assessment, the most highly exposed population subgroup is also all infants (<1 year old; 22% of the cPAD).  The use of ARs, empirical processing factors, and %CT data would refine further HED’s exposure and risk estimates; however, refinements are not needed at this time.

Table 4.  Summary of Dietary Exposure and Risk for MCPB.

Population Subgroup	Acute Dietary1

(95th Percentile)	Chronic Dietary1

	Dietary Exposure (mg/kg/day)	%aPAD*	Dietary Exposure (mg/kg/day)	% cPAD*

U.S. Population (total)	0.002870	1.4	0.000294	6.7

All Infants (< 1 year old)	0.010731   	5.4	0.000977	22

Children 1-2 years old	0.004527   	2.3	0.000455	10

Children 3-5 years old	0.004120   	2.1	0.000415	9.4

Children 6-12 years old	0.002865  	1.4	0.000284	6.5

Youth 13-19 years old	0.002334 	1.2	0.000211	4.8

Adults 20-49 years old	0.002653   	1.3	0.000273	6.2

Adults 50+ years old	0.002408 	1.2	0.000289	6.6

Females 13-49 years old	0.002664 	1.3	0.000271	6.2

1 Acute dietary endpoint of 0.2 mg/kg/day applies to the general U.S. population and all population subgroups.  Chronic dietary endpoint of 0.0044 mg/kg/day applies to the general U.S. population and all population subgroups.

*  The highest %aPAD and %cPAD are bolded.

VII.  List of Attachments

Attachment 1:  DEEM-FCID( Acute Residue Input File.

Attachment 2:  DEEM-FCID( Acute Results File.

Attachment 3:  DEEM-FCID( Chronic Residue Input File.

Attachment 4:  DEEM-FCID( Chronic Results File.

cc:  S. Levy

RDI: DESAC (28-MAR-2008); G. Kramer (30-SEP-2008)

S. Levy:S10953:PY1:(703)305-0783:7590P

Attachment 1:  DEEM-FCID( Acute Residue Input File.

U.S. Environmental Protection Agency                                Ver. 2.02

DEEM-FCID Acute analysis for MCPB

Residue file name: C:\Documents and Settings\slevy\My Documents\SarahLevy's Files\deem\MCPB\019201a.R98

Analysis Date 03-26-2008            Residue file dated: 03-26-2008/16:57:27/8

Reference dose (aRfD) = 0.2 mg/kg bw/day

Comment: no cancer

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

06022550 6B   Pea, succulent                     0.100000   1.000  1.000

06022551 6B   Pea, succulent-babyfood            0.100000   1.000  1.000

95002750 O    Peppermint                         0.200000   1.000  1.000

95002760 O    Peppermint, oil                    0.200000   1.000  1.000

95003520 O    Spearmint                          0.200000   1.000  1.000

95003530 O    Spearmint, oil                     0.200000   1.000  1.000

86010000 O    Water, direct, all sources         0.054700   1.000  1.000

86020000 O    Water, indirect, all sources       0.054700   1.000  1.000Attachment 2:  DEEM-FCID( Acute Results File.

U.S. Environmental Protection Agency                                Ver. 2.02

DEEM-FCID ACUTE Analysis for MCPB                              (1994-98 data)

Residue file: 019201a.R98                         Adjustment factor #2 used.

Analysis Date: 03-26-2008/16:59:21  Residue file dated: 03-26-2008/16:57:27/8

Daily totals for food and foodform consumption used.

Run Comment: "no cancer"

======================================================================== =====

Summary calculations (per capita):

                 95th Percentile      99th Percentile      99.9th Percentile

                Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

U.S. Population:

                 0.002870     1.44    0.005406     2.70    0.010770     5.38

All infants:

                 0.010731     5.37    0.015519     7.76    0.027494    13.75

Males 13-19 yrs:

                 0.002348     1.17    0.004376     2.19    0.009979     4.99

Males 20+ yrs:

                 0.002473     1.24    0.004033     2.02    0.007580     3.79

Seniors 55+:

                 0.002352     1.18    0.003341     1.67    0.005535     2.77

Children 1-2 yrs:

                 0.004527     2.26    0.007600     3.80    0.010856     5.43

Children 3-5 yrs:

                 0.004120     2.06    0.006413     3.21    0.010465     5.23

Children 6-12 yrs:

                 0.002865     1.43    0.004791     2.40    0.006464     3.23

Youth 13-19 yrs:

                 0.002334     1.17    0.003886     1.94    0.007059     3.53

Adults 20-49 yrs:

                 0.002653     1.33    0.004461     2.23    0.007981     3.99

Adults 50+ yrs:

                 0.002408     1.20    0.003430     1.71    0.005587     2.79

Females 13-49 yrs:

                 0.002664     1.33    0.004285     2.14    0.007583     3.79

Attachment 3:  DEEM-FCID( Chronic Residue Input File.

U.S. Environmental Protection Agency                                Ver. 2.00

DEEM-FCID Chronic analysis for MCPB                              1994-98 data

Residue file: C:\Documents and Settings\slevy\My Documents\SarahLevy's Files\deem\MCPB\019201c.R98                                                        Adjust. #2 used

Analysis Date 05-19-2008            Residue file dated: 05-19-2008/14:30:06/8

Reference dose (RfD) = 0.0044 mg/kg bw/day

Comment:no cancer

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

06022550 6B   Pea, succulent                     0.100000   1.000      1.000

06022551 6B   Pea, succulent-babyfood            0.100000   1.000      1.000

95002750 O    Peppermint                         0.200000   1.000      1.000

95002760 O    Peppermint, oil                    0.200000   1.000      1.000

95003520 O    Spearmint                          0.200000   1.000      1.000

95003530 O    Spearmint, oil                     0.200000   1.000      1.000

86010000 O    Water, direct, all sources         0.013500   1.000      1.000

86020000 O    Water, indirect, all sources       0.013500   1.000      1.000

Attachment 4:  DEEM-FCID( Chronic Results File.

U.S. Environmental Protection Agency                                Ver. 2.00

DEEM-FCID Chronic analysis for MCPB                            (1994-98 data)

Residue file name: C:\Documents and Settings\slevy\My Documents\SarahLevy's Files\deem\MCPB\019201c.R98                                                     Adjustment factor #2 used.

Analysis Date 05-19-2008/14:32:31   Residue file dated: 05-19-2008/14:30:06/8

Reference dose (RfD, Chronic) = .0044 mg/kg bw/day

COMMENT 1: no cancer

======================================================================== =====

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000294                 6.7%

U.S. Population (spring season)             0.000292                 6.6%

U.S. Population (summer season)             0.000314                 7.1%

U.S. Population (autumn season)             0.000285                 6.5%

U.S. Population (winter season)             0.000286                 6.5%

Northeast region                            0.000271                 6.2%

Midwest region                              0.000297                 6.8%

Southern region                             0.000280                 6.4%

Western region                              0.000335                 7.6%

Hispanics                                   0.000329                 7.5%

Non-hispanic whites                         0.000287                 6.5%

Non-hispanic blacks                         0.000282                 6.4%

Non-hisp/non-white/non-black                0.000360                 8.2%

All infants (< 1 year)                      0.000977                22.2%

Nursing infants                             0.000371                 8.4%

Non-nursing infants                         0.001206                27.4%

Children 1-6  yrs                           0.000421                 9.6%

Children 7-12 yrs                           0.000269                 6.1%

Females 13-19 (not preg or nursing)         0.000205                 4.7%

Females 20+ (not preg or nursing)           0.000292                 6.6%

Females 13-50 yrs                           0.000282                 6.4%

Females 13+ (preg/not nursing)              0.000288                 6.5%

Females 13+ (nursing)                       0.000402                 9.1%

Males 13-19 yrs                             0.000216                 4.9%

Males 20+ yrs                               0.000263                 6.0%

Seniors 55+                                 0.000289                 6.6%

Children 1-2 yrs                            0.000455                10.3%

Children 3-5 yrs                            0.000415                 9.4%

Children 6-12 yrs                           0.000284                 6.5%

Youth 13-19 yrs                             0.000211                 4.8%

Adults 20-49 yrs                            0.000273                 6.2%

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Adults 50+ yrs                              0.000289                 6.6%

Females 13-49 yrs                           0.000271                 6.2%

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

MCPB	               Dietary Exposure and Risk Assessment  	                          DP#: 350511

PC Code:  019201

________________________________________________________________________ ___________________

Page   PAGE  1  of   NUMPAGES  11

MCPB                                    	Dietary Exposure and Risk Assessment  	                              DP#: 350511

PC Code:  019201

________________________________________________________________________ _____________________


[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80728-80729]
[FR Doc No: 2023-25500]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4718]

Advancing the Development of Therapeutics Through Rare Disease
Patient Community Engagement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Advancing the
Development of Therapeutics Through Rare Disease Patient Community
Engagement.'' Convened by the Duke-Robert J. Margolis, MD Center for
Health Policy (Duke-Margolis) in collaboration with FDA and supported
by a cooperative agreement between FDA and Duke-Margolis, the workshop
will focus on how best to understand patients' experiences living with
a rare disease and how to incorporate those experiences, as well as
patients' priorities for treatment goals, throughout the drug
development process.

DATES: The public meeting will be held virtually on December 14, 2023,
from 12 p.m. to 5 p.m. Eastern Time. Either electronic or written
comments on this public meeting must be submitted by February 12, 2024.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public meeting will be held virtually using the Zoom
platform.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of February 12, 2024. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received 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-2023-N-4718 for ``Advancing the Development of Therapeutics Through
Rare Disease Patient Community Engagement.'' 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
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     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
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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
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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: Stuti Ganatra, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This public meeting is intended to facilitate improvements in the
treatment of rare diseases and conditions, consistent with the
requirements under section 3202 of the Food and Drug Omnibus Reform Act
of 2022 (FDORA). Section 3202 of FDORA requires FDA to conduct a number
of activities related to improving the treatment of rare diseases and
conditions, including the convening of one or more public meetings to
address increasing and improving engagement with rare disease patients,
rare disease patient groups, and experts on small population studies,
in order to improve the understanding of patient burden, treatment
options, and the side effects of treatments (see section 3202(d)(2) of
FDORA).

II. Topics for Discussion at the Public Meeting

    The purpose of this public meeting is to highlight and build upon
existing actionable approaches for engaging patients, patient groups,
and related experts when developing necessary evidence for rare disease
drug approvals. The meeting will address approaches to increasing and
improving engagement with rare disease patients, groups representing
such patients, rare disease experts, and experts on small population
studies, to improve the understanding of how to best understand
patients' experiences living with a rare disease and how to incorporate
those experiences and priorities throughout the drug development
process. This includes understanding patient perspectives on the burden
of their condition and any existing treatment options, as well as how
their current health status and risk of disease progression may impact
willingness to accept risks from treatment side effects.
    Meeting updates, the agenda, and background materials (if any) will
also be made available at https://duke.is/4/7yuu prior to the meeting.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://duke.is/4/7yuu. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Registration will end at
11:59 p.m. Eastern Time on December 13, 2023.
    Registration is free and persons interested in attending this
public meeting must register to receive a link to the meeting.
Registrants will receive a confirmation email after they register.
    If you need special accommodations due to a disability, please
contact [email protected] no later than November 30, 2023. Please
note, closed captioning will be available automatically.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://duke.is/4/7yuu. The transcript will also be available at https://www.regulations.gov and may be viewed at the Dockets Management Staff
(see ADDRESSES).

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25500 Filed 11-17-23; 8:45 am]
BILLING CODE 4164-01-P