MEMORANDUM

TO:		Public Record for the NPDES Electronic Reporting Rule
		EPA Docket Number EPA-HQ-OECA-2009-0274 (www.regulations.gov)

FROM:		Carey A. Johnston, P.E.
            USEPA/OECA/OC
            ph:<PHONE_NUMBER>
<EMAIL_ADDRESS>
DATE:		14 September 2015

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SUBJECT:	Notes from Technical Meeting with States (2 April 2015) [DCN 0226]
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Overview

      This was the twenty-fourth meeting between EPA and individual representatives from authorized NPDES programs. These meetings provided greater clarity regarding public comments on the NPDES Electronic Reporting Rule (eRule). Participants are listed below in Tables 1 and 2. EPA is summarizing the notes from these discussions for the docket in order to provide transparency on EPA's outreach during the rulemaking process (see Table 3). EPA also met with other stakeholders to discuss public comments.

Meeting Notes

     EPA (Mr. Carey Johnston) started the meeting by reminding state participants that in addition to raising questions during these meetings, states can email their questions on the proposed rule (including the data elements) to EPA. Questions on all aspects of the proposed rule can be sent to Mr. Johnston. Mr. Johnston also reminded everyone that this outreach does not constitute a decision-making body (see "Quick Reminder" section below).

     Mr. Johnston started the technical discussion by reading the name of each sewage sludge/biosolids element along with the corresponding data description and regulatory or policy citation. After reading about five to ten elements at a time, Mr. Johnston asked for input from meeting participants. Below are some questions and comments from the meeting participants.

* A representative from New Jersey noted that they collect biosolids information on their NPDES permit application forms.

* Several state government representatives asked EPA to streamline the biosolids data elements that are reported on the NPDES permit application. EPA was able to streamline these data elements and provided clarifying language in the data descriptions.

* New Jersey noted that they don't use the term `biosolids' as it is not defined in the EPA's biosolids regulations (40 CFR 503). In the final rule EPA add the following note to Appendix A: "For the purposes of this Appendix, the term `sewage sludge' [see 40 CFR 503.9(w)] also refers to the material that is commonly referred to as `biosolids.' EPA does not have a regulatory definition for biosolids but this material is commonly referred to as sewage sludge that is placed on, or applied to the land to use the beneficial properties of the material as a soil amendment, conditioner, or fertilizer. EPA's use of the term `biosolids' in this Appendix is to confirm that information about beneficially used sewage sludge (a.k.a. biosolids) is part of the data collected in this Appendix." EPA also changed the title of the annual report to, "Sewage Sludge/Biosolids Annual Program Report."

      Following the meeting, EPA received an e-mail from an individual state government representative on the data elements reviewed in this meeting. This e-mail is provided in Attachment 1.

Quick Reminder
   *    The technical workgroup is not a decision-making body. Members of the workgroup provide clarity on their comments and suggest options for consideration by EPA and state senior management.

   *    There are no formal quorum rules for the workgroup. Scheduled teleconferences will proceed with whichever workgroup members call in to participate.

   *    There will be no voting or consensus of the workgroup. Instead, members of the workgroup are providing individual input reflecting their various perspectives.

   *    Summaries of the workgroup's discussions will be prepared for and reviewed by the workgroup, for presentation to EPA senior management and other states and the rulemaking record.

Table 1: State Technical Workgroup Members  -  2 April 2015

                                 Main Contact
                             State or Organization
                              Main Contact Email
                         State/Org. Present? (Yes/No)
                                 Sean  Rolland
                                     ACWA
<EMAIL_ADDRESS>                                      Yes
                                 Karen Lechner
                                      AK
<EMAIL_ADDRESS>                                      Yes
                                 Christy Monk
                                      AL
<EMAIL_ADDRESS>                                      Yes
                                 Eric Cleckler

<EMAIL_ADDRESS>
                                  Glenda Dean

<EMAIL_ADDRESS>
                                 Teresa Marks
                                      AR
<EMAIL_ADDRESS>                                      Yes
                                   Pat Goff

<EMAIL_ADDRESS>
                                   Mo Shafii

<EMAIL_ADDRESS>
                                 Karen Bassett

<EMAIL_ADDRESS>
                                 David Ramsey

<EMAIL_ADDRESS>
                                Ellen Carpenter

<EMAIL_ADDRESS>
                                Wendy LeStarge
                                      AZ
<EMAIL_ADDRESS>                                      No
                                 Robin Belley

<EMAIL_ADDRESS>
                                  David Lelsz

<EMAIL_ADDRESS>
                         Darren Polhemus
                                      CA
<EMAIL_ADDRESS>                                      No
                       Renee Purdy

<EMAIL_ADDRESS>
                        Deborah Smith

<EMAIL_ADDRESS>
                       Vicky Whitney

<EMAIL_ADDRESS>
                                  Andy Putnam
                                      CO
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      Yes
                                 Elisa Willard

<EMAIL_ADDRESS>
                                 Bob Zimmerman
                                      DE
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      No
                                   Tom Tyler
                                     ECOS
<EMAIL_ADDRESS>                                      No
                                  Chris Klena
                                      FL
<EMAIL_ADDRESS>                                      Yes
                              Jessica Kleinfelter

<EMAIL_ADDRESS>
                                 Edward Smith

<EMAIL_ADDRESS>

                               Frances Carpenter
                                      GA
<EMAIL_ADDRESS>                                      Yes
                                Scott Miyashiro
                                      HI
<EMAIL_ADDRESS>                                      Yes
                                 Tom Easterly
                                      IN
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      Yes
                               Jeremy Chenevert

<EMAIL_ADDRESS>
                                 Mark Stanifer

<EMAIL_ADDRESS>
                               Courtney Cswercko
                                      IA
<EMAIL_ADDRESS>                                      No
                                 Ed Dillingham
                                      KS
<EMAIL_ADDRESS>                                      No
                                 Steve Caspers

<EMAIL_ADDRESS>
                             Shelly Shores-Miller

<EMAIL_ADDRESS>
                                Shawn Hokanson
                                      KY
<EMAIL_ADDRESS>                                      No
                                  Grace Scott
                                      MI
<EMAIL_ADDRESS>                                      Yes
                                Carla Davidson

<EMAIL_ADDRESS>
                                 Ruth Wallace
                                      MO
<EMAIL_ADDRESS>                                      No
                                  Walter Fett

<EMAIL_ADDRESS>
                              Christopher Miller

<EMAIL_ADDRESS>
                                  Tamara Dahl
                                      MN
<EMAIL_ADDRESS>                                      No
                                 Paul Scheirer

<EMAIL_ADDRESS>
                                  John Murphy
                                    NEIWPCC
<EMAIL_ADDRESS>                                      No
                        Deborah Gore
                                      NC
<EMAIL_ADDRESS>                                      No
                        Bradley Bennett

<EMAIL_ADDRESS>
                                 Jason Lonardo
                                      NJ
<EMAIL_ADDRESS>                                      Yes
                                 Julio Collazo

<EMAIL_ADDRESS>
                                 Robert Wither
                                      NY
<EMAIL_ADDRESS>                                      Yes
                                 Joseph DiMura

<EMAIL_ADDRESS>
                      Alan Tinney
                                  Dave Gaskin
                                      NV
<EMAIL_ADDRESS>                                      Yes

<EMAIL_ADDRESS>
                    Brian Hall
                                      OH
<EMAIL_ADDRESS>                                      No
                     Erin Sherer

<EMAIL_ADDRESS>
                             Shellie Chard-McClary
                                      OK
<EMAIL_ADDRESS>                                      Yes
                                  Roy Walker

<EMAIL_ADDRESS>
                                 David Pruitt

<EMAIL_ADDRESS>
                                 Jim Billings
                                      OR
<EMAIL_ADDRESS>                                      Yes
                                 Sean Furjanic
                                      PA
<EMAIL_ADDRESS>                                      No
                                Kent Woodmansey
                                      SD
<EMAIL_ADDRESS>                                      Yes
                                   Tim Flor

<EMAIL_ADDRESS>
                                Albert Spangler

<EMAIL_ADDRESS>
                               Lawrence Bunting
                                      TN
<EMAIL_ADDRESS>
                                      Yes
                                 Yatasha Moore

<EMAIL_ADDRESS>

                                  Kim Wilson
                                      TX
<EMAIL_ADDRESS>                                      Yes
                               Rebecca Villalba

<EMAIL_ADDRESS>
                                 Lynley Doyen

<EMAIL_ADDRESS>
                               Kimberly Shepard

<EMAIL_ADDRESS>
                                 Jeff Studenka
                                      UT
<EMAIL_ADDRESS>                                      No
                                 Jerome Brooks
                                      VA
<EMAIL_ADDRESS>                                      Yes
                                Deborah Debiasi

<EMAIL_ADDRESS>
                                  Phani Eturu

<EMAIL_ADDRESS>
                                Stephen Bernath
                                      WA
<EMAIL_ADDRESS>                                      Yes
                                  Dave Knight

<EMAIL_ADDRESS>
                                  Nancy Kmet

<EMAIL_ADDRESS>
Table 2: EPA Technical Workgroup Members

                                     Name
                                  EPA Office
                                     Email
                               Present? (Yes/No)
                                John Dombrowski
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      No
                                  Andy Hudock
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      Yes
                                Rochele Kadish
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      No
                                Carey Johnston
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      Yes
                                 Jackie Clark
                                  OW/OWM/WPD
<EMAIL_ADDRESS>                                      Yes
                                  Jan Pickrel
                                  OW/OWM/WPD
<EMAIL_ADDRESS>                                      Yes
                                Ginny Phillips
                                 OECA/OCE/WED
<EMAIL_ADDRESS>                                      Yes
                                 Aditi Prabhu
                                    OGC/WLO
<EMAIL_ADDRESS>                                      No
                                 David Apanian
                                   Region 4
<EMAIL_ADDRESS>                                      Yes
                                  Sandra Chew
                                   Region 9
<EMAIL_ADDRESS>                                      No
                                  Glynis Hill
                                 OP/ORPM/PRAD
<EMAIL_ADDRESS>                                      No

Table 3: State Technical Workgroup Discussions to Discuss Public Comments

                                      DCN
                                     Date
Topic
Data Source
                                   DCN 0219
                                  02/05/2015
Basic Facility and Permit Data
Ind. Permit Applications/NOIs
                                   DCN 0220
                                  02/12/2015
Basic Violation and Enforcement Action Data
States & Ind. Permit Applications/NOIs
                                   DCN 0221
                                  02/26/2015
Municipal Separate Storm Sewer System (MS4) Information
Ind. Permit Applications/NOIs & MS4 Program Report
                                   DCN 0222
                                  03/05/2015
Construction and Industrial Stormwater Information
Ind. Permit Applications/NOIs
                                   DCN 0223
                                  03/12/2015
CSO & Collection System Information & Sewer Overflow Data
Ind. Permit Applications/NOIs & Sewer Overflow Event Reports
                                   DCN 0224
                                  03/19/2015
Pretreatment Data
Ind. Permit Applications/NOIs & Annual POTW Pretreatment Program Reports, CIU/SIU Reports When EPA or State is Control Authority
                                   DCN 0225
                                  03/26/2015
Cooling Water and Thermal Variance Data
Ind. Permit Applications/NOIs
                                   DCN 0226
                                  04/02/2015
Biosolids Data
States & Ind. Permit Applications/NOIs & Annual Biosolids Reports
                                   DCN 0227
                                  04/09/2015
CAFO Data
Ind. Permit Applications/NOIs & Annual Biosolids Reports
                                   DCN 0228
                                  05/13/2015
Review of Appendix A
All NPDES program data
                                   DCN 0229
                                  05/27/2015
Review of State Representative Questions to EPA
All NPDES program data

    Attachment 1 - Email from Representative from Authorized NPDES Program
E-mail from Lawrence Bunting<EMAIL_ADDRESS>Thu 4/2/2015 2:23 PM
Biosolids for our state are handled in Region 4, so TDEC has less of a stake in the data elements for biosolids.  I don't have any comment on the data elements.
My biggest question from the call is, "How information will be stored in the ICIS-NPDES data structure?"  If multiple city sewage plants are sending biosolids to a third party making land application, there may be one field with loading rates that are a combined loading from separate permits.  When the third party reports back to the facility or reports to EPA, how will it tie information back to the generator?  If there are 4 facilities supplying biosolids, is the loading parsed out between the four to be reported to ICIS-NPDES?  I presume that a third party may have more than one application site to use.  This gets into a many-to-many database relationship where it could be difficult to track for a particular permit number in ICIS-NPDES.  If there is a bad actor in the group, the database needs to be structured such that the entity responsible is tagged but the innocent are not held to account for someone else's problem.
EPA RESPONSE: EPA has structured the data elements to provide the necessary linkages between NPDES regulated entities. EPA will work with authorized NPDES programs to provide the necessary training and guidance to properly implement this final rule.
Another question in my mind is how permit application data will be shared between state and EPA.  In the case of TN, the state issues the NPDES permit and EPA Region 4 handles the biosolids.  The two will probably need to share/coordinate information.
EPA RESPONSE: Authorized NPDES programs will continue to collect the biosolids data on NPDES permit applications, as required by existing EPA regulations, and then share these data with EPA's national NPDES data system through timely data sharing practices as outlined by the final rule.


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Page 41397]
[FR Doc No: 2012-17149]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-853-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: VPEM Negotiated Rate Correction to be effective 4/1/
2012.
    Filed Date: 7/5/12.
    Accession Number: 20120705-5033.
    Comments Due: 5 p.m. ET 7/17/12.

    Docket Numbers: RP12-854-000.
    Applicants: Honeoye Storage Corporation.
    Description: Priority Non-Firm Storage Service Filing to be
effective 8/1/2012.
    Filed Date: 7/6/12.
    Accession Number: 20120706-5019.
    Comments Due: 5 p.m. ET 7/18/12.

    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
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: July 6, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-17149 Filed 7-12-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 105 (Thursday, June 1, 2023)]
[Notices]
[Pages 35995-35998]
[FR Doc No: 2023-11576]

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

Office of the Secretary of Transportation

Notice of Funding Opportunity for Letters of Interest for the
RRIF Express Pilot Program Under the Railroad Rehabilitation &
Improvement Financing Program

AGENCY:  Office of the Secretary of Transportation, Department of
Transportation (the ``DOT'').

ACTION: Notice of funding opportunity.

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SUMMARY: This Notice of Funding Opportunity (``NOFO'') for the RRIF
Express Pilot Program (``RRIF Express'') expands the ability of
eligible borrowers to access funds by removing the caps on Cost
Assistance for advisor fees and Credit Risk Premium (``CRP'')
Assistance, provides greater flexibility by allowing unaudited
financial statements in lieu of audited financial statements in certain
circumstances, and makes other clarifications. The NOFO also implements
a sunset date of December 1, 2023. Following the sunset date, this NOFO
will expire, and all benefits made available in this Notice will become
available to any eligible RRIF borrower, consistent with existing law.
All projects that were previously eligible for RRIF Express financing
remain eligible under this NOFO. The original NOFO with modifications
is in the SUPPLEMENTARY INFORMATION section.

DATES: Letters of Interest from prospective RRIF borrowers for RRIF
Express will be accepted on rolling basis until available funding is
expended or this notice is superseded by another notice.
    Prospective RRIF borrowers that have previously submitted a Letter
of Interest, but that also seek acceptance into the RRIF Express Pilot
Program should resubmit a Letter of Interest following the instructions
below. Prospective RRIF borrowers who previously submitted Letters of
Interest under a preceding RRIF Express Notice of Funding Opportunity
(published on December 13, 2019, March 16, 2020, June 19, 2020, or
November 27, 2020), and whose Letters of Interest have not been
returned as ineligible, do not have to re-apply, and may amend their
Letter of Interest to take advantage of the provisions of this NOFO.
Prospective RRIF borrowers whose Letter of Interest for RRIF Express
was returned by the Bureau with advice on issues to address in
resubmitting a Letter of Interest may also take advantage of the
provisions of this NOFO while also following the advice provided.
    Irrespective of the above, the Bureau continues to accept Letters
of Interest on a rolling basis from any prospective RRIF borrower
interested in receiving RRIF credit assistance only (i.e., without
participation in RRIF Express).

ADDRESSES: Applicants to RRIF Express must use the latest version of
the Letter of Interest form available on the Build America Bureau
website: https://www.transportation.gov/content/build-america-bureau
(including applicants who have previously submitted Letters of Interest
and who are now seeking participation in RRIF Express). Letters of
Interest must be submitted to the Build America Bureau via email at:
[email protected] using the following subject line: ``Letter of
Interest for RRIF Express Program.'' Submitters should receive a
confirmation email, but are advised to request a return receipt to
confirm transmission. Only Letters of Interest received via email at
the above email address with the subject line listed above shall be
deemed properly filed.

FOR FURTHER INFORMATION CONTACT: For further information regarding this
notice please contact William Resch via email at [email protected]
or via telephone at<PHONE_NUMBER>. A TDD is available at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: RRIF Express is administered by the DOT's
National Surface Transportation and Innovative Finance Bureau (the
``Build America Bureau'' or ``Bureau''). The overall RRIF program
finances development of railroad infrastructure and is authorized to
have up to $35 billion in outstanding principal amounts from direct
loans and loan guarantees at any one time.
    The 2018 Consolidated Appropriations Act \1\ appropriated $25
million in budget authority to the DOT to cover the cost to the Federal
Government (the ``Government'') of RRIF credit assistance--CRP
assistance. Additionally, the 2016 Consolidated Appropriations Act \2\
and the 2018 Consolidated Appropriations Act \3\ provided $1.96 million
and $350,000, respectively (of which approximately $1 million remains
available), to the DOT to fund certain expenses incurred by prospective
RRIF borrowers in preparation of their applications for RRIF credit
assistance (this approximately $1 million assistance, collectively,
``Cost Assistance''). Using existing authorities and these new budget
authorities, the DOT has established RRIF Express.
---------------------------------------------------------------------------

    \1\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
    \2\ Public Law 114-113, div. L, tit. I, Sec.  152, 129 Stat.
2242, 2856.
    \3\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

    Subject to the availability of funds, applicants accepted into the
RRIF Express Pilot Program may benefit from two types of financial
assistance: (a) Cost Assistance to pay for any portion of the Bureau's
advisor expenses borne by applicants; and (b) for those applicants that
ultimately receive RRIF credit assistance, CRP Assistance to pay the
CRP normally paid by the borrower. These funds will be made available
to benefit applicants accepted into RRIF Express on a first come, first
served basis until each source of funding is expended or this notice is
superseded by a new Notice of Funding Opportunity. Letters of Interest
will be accepted in the order received and will be allocated Cost
Assistance based on the date of acceptance into RRIF Express. CRP
Assistance will be allocated in the order of financial close. For more
information about potential financial assistance for RRIF Express
applicants, see SUPPLEMENTARY INFORMATION: Section II. Funding of CRP
and Cost Assistance.
    This notice solicits Letters of Interest from prospective RRIF
borrowers seeking assistance from RRIF Express, establishes eligibility
criteria, and describes the process that prospective borrowers must
follow when submitting Letters of Interest.
    RRIF Express information, including any additional resources,
terms, conditions and requirements when they become available, can be
found on the Build America Bureau website at: https://www.transportation.gov/buildamerica/rrif-express. For further
information about the overall RRIF program in general, including
details about the types of credit assistance available, eligibility
requirements and the creditworthiness review process, please refer to
the Build America Bureau Credit Programs Guide (``Programs Guide),''
available on the Build America Bureau website: https://www.transportation.gov/buildamerica/financing/program-guide.

Table of Contents

I. Background
II. Funding of CRP Assistance and Cost Assistance
III. Eligibility Requirements for RRIF Credit Assistance
IV. Eligibility Criteria for RRIF Express
V. Letter of Interest Process and Review and Next Steps

I. Background

    The Transportation Equity Act for the 21st Century,\4\ established
the RRIF program, authorizing the DOT to provide credit assistance in
the form of direct loans and loan guarantees to public and private
applicants for eligible railroad projects. The RRIF program is a DOT
program and final approval of credit assistance is reserved for the
Secretary of the DOT. The 2005 Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users; \5\ the Rail Safety
Improvement Act of 2008; \6\ and the 2015 Fixing America's Surface
Transportation Act \7\ (the ``FAST Act'') each made a number of changes
to the RRIF program. In addition, the FAST Act authorized the creation
of the Bureau to consolidate administration of certain DOT credit and
grant programs, including the RRIF program.
---------------------------------------------------------------------------

    \4\ Public Law 105-178, Sec.  7203, 112 Stat. 107, 471.
    \5\ Public Law 109-59, Sec.  9003, 119 Stat. 1144, 1921.
    \6\ Public Law 110-432, Sec.  701(e), 122 Stat. 4848, 4906.
    \7\ Public Law 114-94, Subtitle F, 129 Stat. 1312, 1693.
---------------------------------------------------------------------------

II. Funding of CRP Assistance and Cost Assistance

    Through the RRIF program, the DOT is authorized to have, at any one
time, up to $35 billion in unpaid principal amounts of obligations
under direct loans and loan guarantees to finance development of
railroad infrastructure.

CRP Assistance

    Prior to the 2018 Consolidated Appropriations Act, the RRIF program
did not have an appropriation of budget authority to pay the cost to
the Government of providing RRIF credit assistance. As a result, the
RRIF borrower or a third party was required to bear this cost through
the payment of a CRP. The 2018 Consolidated Appropriations Act \8\
provided $25 million to the DOT to cover the cost to the Government of
RRIF credit assistance. The DOT will use this funding to pay any CRP
that would otherwise be payable by participants in RRIF Express, until
this funding is expended, or this notice is superseded by a new Notice
of Funding Opportunity.
---------------------------------------------------------------------------

    \8\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

Cost Assistance

    As described in the Programs Guide, RRIF borrowers are required to
pay (or reimburse the DOT) for costs incurred by the Bureau in
connection with the review of Letters of Interest and applications for
RRIF credit assistance. The 2016 Consolidated Appropriations Act \9\
and the 2018 Consolidated Appropriations Act \10\ collectively provided
$2.31 million to the DOT to be used to fund expenses incurred by
prospective RRIF borrowers in preparation to apply for RRIF credit
assistance. A portion of these funds have already been allocated for
prior RRIF projects. The DOT is reserving approximately $1 million of
remaining funds from these appropriations to offset the cost of DOT
advisors that would be payable by participants in RRIF Express, until
this funding is expended, or this notice is superseded by a new Notice
of Funding Opportunity.
---------------------------------------------------------------------------

    \9\ Public Law 114-113, div. L, tit. I, Sec.  152, 129 Stat.
2242, 2856.
    \10\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

III. Eligibility Requirements for RRIF Credit Assistance

    The RRIF statute and implementing rules set forth eligibility
requirements for applicants and projects. These requirements as well as
other applicable federal requirements are described in detail in the
Programs Guide and apply to all applicants and projects, including
those seeking acceptance into RRIF Express. In addition, for
prospective borrowers seeking RRIF Express benefits, the requirements
set forth in section IV (Eligibility Criteria for RRIF Express) of this
notice also apply.

IV. Eligibility Criteria for RRIF Express

    The DOT has identified the following strategic objectives for RRIF
Express: encouraging increased utilization of RRIF credit assistance by
Class II and Class III railroads; reducing transaction costs for Class
II and Class III railroads; and streamlining the underwriting process
for Class II and Class III railroads. These priorities are reflected in
the eligibility criteria below. Generally, projects most suitable for
RRIF Express are rail line modernization projects where the borrower
has a well-documented financial history and easily identified revenue
stream(s) for loan repayment.
    To differentiate among Letters of Interest received for projects
under this NOFO, the DOT will consider whether the project satisfies
the following eligibility criteria as demonstrated by the Letter of
Interest:
    (i) Applicant: The applicant must be a Class II railroad, a Class
III railroad, a commuter railroad or a joint venture with a Class II,
III, or commuter railroad.
    (ii) Project Size: The project must have eligible project costs of
$150 million or less with no minimum amount.
    (iii) Project Scope: The project scope, as described in Section B4
of the Letter of Interest, must be limited to the support of railroad
activities that are otherwise eligible for RRIF financing and as
outlined below:
    (a) Acquire, improve, or rehabilitate intermodal or rail equipment
or facilities, including track, components of track, bridges, yards,
buildings, and shops, and costs related to these activities, including
pre-construction costs. Note that this category of eligible activities
includes the installation of positive train control systems;
    (b) Develop or establish new intermodal or railroad facilities;
    (c) Reimburse planning and design expenses relating to activities
listed above;
    (d) Refinancing of non-federal debt incurred at least three years
prior to the date of acceptance into RRIF Express and for the purpose
of one or more of the following activities: (1) acquire, improve, or
rehabilitate intermodal or rail equipment or facilities, including
track, components of track, bridges, yards, buildings, and shops, and
costs related to these activities, including pre- construction costs;
and (2) develop or establish new intermodal or railroad facilities;
Refinancing is limited to up to 75% of the final RRIF loan amount.
    Letters of Interest including refinancing must demonstrate with
specificity in Section D5 how the refinancing would improve the
creditworthiness of the applicant and document how such improvement
would facilitate the activities referenced in items (a) and (b) above
and would increase the applicant's ability to repay a RRIF loan and the
overall financial health of the applicant.
    (iv) Applicant Financial History and Projections: Attachment D-1 of
the Letter of Interest must \11\ include audited financial statements
(by a qualified third party, e.g., a certified public accountant) for
the two (2) most recent consecutive years preceding the year of
application and that have no significant unresolved findings (e.g.,
fiscal years 2018 and

2019). Interim unaudited financial statements may be submitted with a
letter pledging to provide these audited statements within 60 days of
submitting of the LOI and supporting materials. Failure to provide the
audited financial statements within 60 days will disqualify the LOI.
Applicants choosing this option must still provide unaudited financial
statements for the previous five years and prospective financial
projections (pro-forma) for the term of the loan. In lieu of providing
audited financial statements as documentation of historical financial
information in Attachment D-1 of the Letter of Interest, an applicant
meeting the size standard for small business concerns established under
section 3(a)(2) of the Small Business Act (15 U.S.C. 632(a)(2)) may
provide unaudited financial statements if such statements are
accompanied by the applicant's Federal tax returns and Internal Revenue
Service tax verifications for the corresponding years. Borrowers
exercising this option should note that it may impact the time required
to process their application.
---------------------------------------------------------------------------

    \11\ Certain applicants may not need to provide audited
financial statements, as explained in more detail below.
---------------------------------------------------------------------------

    (v) Collateral: If collateral will be pledged for the RRIF loan,
Section D9 of the Letter of Interest must be supported with an
independent appraisal of the collateral that must have been completed
within the past 12 months preceding submission of an LOI. Section D9 of
the Letter of Interest must demonstrate that the collateral will be
unencumbered at time of closing, including a description of any lien
release process that would occur prior to closing on the RRIF loan to
render currently pledged collateral unencumbered.
    (vi) Environmental Documentation: Section B6 and Attachment B-6 of
the Letter of Interest must demonstrate that either NEPA review is
complete or the project is likely to qualify for a Categorical
Exclusion (CE) or Finding of No Significant Impact (FONSI) under NEPA.
If a NEPA review has not been completed, Attachment B-6 must include a
Federal Railroad Administration (FRA) CE worksheet with its Letter of
Interest. Where appropriate, the CE worksheet must include substantive
analysis of potential impacts to environmental resources and indicate
the sources of the information or data used to reach conclusions. For
some project types, the CE worksheet will satisfy NEPA review and
documentation requirements; however, for other project types, the CE
worksheet will inform FRA with sufficient details about the project
scope and potential environmental impacts to determine if an
Environmental Assessment (EA) is required. The Applicant would be
responsible for providing sufficient information and funding for the
preparation of an EA, which would also extend the duration of project
development activities. FRA may require the use of a third-party
contractor consistent with 23 CFR 771.109 (e) for the preparation of an
EA. In the event that an EA is necessary, eligible projects must
receive a FONSI to qualify for RRIF Express.
    To help address compliance with Section 106 of the National
Historic Preservation Act, supporting documentation must be submitted
for projects involving reconstruction or replacement of existing
railroad bridges, tunnels, culverts, stations, or depots that assesses
the eligibility of these architectural properties for listing in the
National Register of Historic Places. Supporting documentation must
also be provided for projects involving ground-disturbing site
preparation and construction activities in areas that have not been
previously disturbed (such as by prior land development, agricultural
activities, or the placement of fill), that assesses the archaeological
sensitivity of the project area.
    (vii) Domestic Preference: Section B4(a) of the Letter of Interest
must demonstrate that the steel, iron, manufactured goods, and
construction materials used in the project will be produced in the
United States in accordance with the Build America, Buy America Act
(BABA), Public Law 117-58, 70914 and the Federal Railroad
Administration RRIF Buy America policy, which follows 49 U.S.C.
22905(a). Projects that require a waiver are not eligible for RRIF
Express, however, prospective borrowers can seek a loan from the
overall RRIF program for projects that require a waiver.
    (viii) Project Readiness: Section B4(c) of the Letter of Interest
must demonstrate the prospective borrower's ability to commence the
contracting process for construction of the project (e.g., issuance of
a final RFP) by not later than 90 days after the date on which a RRIF
credit instrument is obligated for the project.

V. Letter of Interest Process and Review and Next Steps

A. Submission of Letters of Interest

    All prospective borrowers seeking acceptance into RRIF Express
should submit a Letter of Interest following the instructions described
in this notice of funding opportunity. The Letter of Interest should be
annotated with ``RRIF EXPRESS'' immediately following the Applicant
Name in the Summary Information section on page one of the Letter of
Interest. The Letter of Interest must, among other things:
    (i) Describe the project and its components, location, and purpose
in Section B, and include as Attachment B-2 the project budget
organized according to construction elements from preliminary
engineering estimates, and including costs as appropriate for property,
vehicles, professional services, allocated and unallocated contingency,
and finance charges;
    (ii) Outline the proposed financial plan in Section C, and include
the financial model, that addresses such aspects as model assumptions,
annual cash flows, balance sheets, income statements and repayment
schedules for the duration of the loan, as well as coverage ratios and
debt metrics. The model should allow reviewers the flexibility to
evaluate scenarios in the native spreadsheet (Microsoft Excel, or
equivalent) format and be included in the application as Attachment C-
1;
    (iii) Provide information regarding satisfaction of other statutory
eligibility requirements of the RRIF credit program; and
    (iv) Provide information regarding satisfaction of RRIF Express
eligibility criteria (as described in Section IV above).
    Prospective RRIF Express borrowers should describe in Letter of
Interest Section D8 if the project will (1) decrease transportation
costs and improve access, especially for rural communities or
communities in Opportunity Zones,\12\ through reliable and timely
access to employment centers and job opportunities; (2) improve long-
term efficiency, reliability or costs in the movement of workers or
goods; (3) increase the economic productivity of land, capital, or
labor, including assets in Opportunity Zones; (4) result in long-term
job creation and other economic opportunities; or (5) help the United
States compete in a global economy by facilitating efficient and
reliable freight movement. Projects that bridge gaps in service in
rural areas, and projects that attract private economic development,
all support local or regional economic competitiveness.
---------------------------------------------------------------------------

    \12\ See https://www.cdfifund.gov/Pages/Opportunity-Zones.aspx
for more information on Opportunity Zones.
---------------------------------------------------------------------------

    Letters of Interest must be submitted using the latest form on the
Build America Bureau website: https://www.transportation.gov/content/build-america-bureau. Other RRIF Express information including any
additional terms, conditions, and requirements can

be found on the Build America Bureau website at: https://www.transportation.gov/buildamerica/rrif-express. The Bureau may
contact a prospective borrower for clarification of specific
information included in the Letter of Interest. The Bureau will review
all Letters of Interest properly filed and received in the submission
time window provided herein.

B. Review and Evaluation

    Each Letter of Interest that is properly filed and received will be
evaluated for completeness and eligibility for RRIF Express using the
criteria in this notice. This initial step of the review process will
include (1) an evaluation as to whether the proposed project and
applicant satisfy RRIF statutory eligibility requirements, and (2) an
evaluation as to whether the proposed project and applicant satisfy
RRIF Express eligibility criteria. In addition, the Bureau will conduct
a high- level feasibility assessment of the proposed project and the
applicant's plan of finance before a Letter of Interest is accepted
into RRIF Express and before a Letter of Interest enters the
creditworthiness process. With respect to the project, factors that
will be considered include, but are not limited to, (1) the completion
of the project being financed is not necessary to repay the proposed
RRIF loan; (2) the project budget is in year of expenditure and
includes contingencies to account for potential project risks; and (3)
the maturity of the proposed RRIF loan does not extend beyond the
project's anticipated useful life. With respect to the applicant's plan
of finance, factors that will be considered include, but are not
limited to, (1) a maximum loan size that, when added to the proposed
borrower's existing outstanding and undrawn available debt, does not
substantially exceed an earnings before interest, taxes, depreciation,
and amortization multiple that would be market appropriate in a similar
circumstance, for the most recent trailing twelve month period and for
any period of the applicant's forecast; and (2) consistent levels of
revenue and operating profitability demonstrated by the proposed
borrower over the most recent fiscal year.
    The Letters of Interest determined to be eligible for RRIF Express
will then be advanced to the Bureau's creditworthiness review process,
which is an in-depth creditworthiness review of the project sponsor and
the revenue stream proposed to repay the RRIF credit assistance as
described in the Programs Guide. The Secretary reserves the right to
limit the number of applications from a single entity or subordinates
of a single parent or holding company. Prospective RRIF borrowers whose
RRIF Express Letters of Interest are determined to be ineligible, but
whose projects are otherwise statutorily eligible for standard RRIF
credit assistance, have the option to be considered under the overall
RRIF program.

    Issued in Washington, DC.
Peter Paul Montgomery Buttigieg,
Secretary of Transportation.
[FR Doc. 2023-11576 Filed 5-31-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Notices]
[Page 15237]
[FR Doc No: 2021-05795]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4570-DR; Docket ID FEMA-2021-0001]

Louisiana; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4570-DR), dated
    October 16, 2020, and related determinations.

DATES: This amendment was issued January 27, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of October 16, 2020.

    Acadia, Cameron, and Jefferson Davis Parishes for permanent work
[Categories C-G] (already designated for Individual Assistance and
debris removal and emergency protective measures [Categories A and
B], including direct federal assistance, under the Public Assistance
program).
    Caldwell and Evangeline Parishes for permanent work [Categories
C-G] (already designated for debris removal and emergency protective
measures [Categories A and B], including direct federal assistance,
under the Public Assistance program).
    Catahoula and East Feliciana Parishes for debris removal
[Category A] and permanent work [Categories C-G] (already designated
for emergency protective measures [Category B], including direct
federal assistance, under the Public Assistance program).
    Richland Parish for debris removal [Category A] and permanent
work [Categories C-G] (already designated for emergency protective
measures [Category B], limited to direct federal assistance, under
the Public Assistance program).
    Union Parish for permanent work [Categories C-G] (already
designated for emergency protective measures [Category B], limited
to direct federal assistance, under the Public Assistance program).
    West Feliciana for debris removal [Category A] (already
designated for emergency protective measures [Category B], including
direct federal assistance, under the Public Assistance program).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-05795 Filed 3-19-21; 8:45 am]
BILLING CODE 9111-23-P


14635 Federal Register / Vol. 68, No. 58 / Wednesday, March 26, 2003 / Notices 6. Prenatal and postnatal sensitivity. The rationale for retaining the 10X FQPA safety factor is explained below: i. There is evidence of increased susceptibility of offspring following in utero exposure to vinclozolin in the prenatal developmental toxicity study in rats. ii. A developmental neurotoxicity study in rats with an expanded protocol is required for vinclozolin as a result of concern for the anti androgenic properties of vinclozolin and its metabolites.

G. Conclusion Based on the developmental and reproductive data for vinclozolin, EPA determined that an additional 10X safety factor for the protection of infants and children ( as required by FQPA) should be retained. 1. Acute risk. No study with vinclozolin indicated that acute exposure to vinclozolin is likely to cause an adverse effect of concern on infants or children or the general public with the exception of the in utero effects on the developing fetus. Risks to the fetus are estimated by examining exposure to women of child bearing age. 2. Chronic risk. Using the exposure assumptions described in this unit, it is concluded that aggregate exposure to vinclozolin from food will utilize 7% of the cPAD for infants and children. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Since the EEC's for residues of vinclozolin per se are lower than the chronic DWLOC's, aggregate exposure will not exceed 100% of the cPAD. 3. Short or intermediate term risk. The MOE is greater than or equal to 1,010 for aggregate risks to infants and children resulting from use of vinclozolin. Therefore, the risks do not exceed the Agency's LOC. 4. Determination of safety. Based on these risk assessments, there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to vinclozolin residues.

H. International Tolerances CODEX maximum residue limits ( MRLs) for residues of vinclozolin and its metabolites containing the 3,5 DCA moiety have been established in common bean at 2 ppm, rape seed at 1 ppm ( no limit for canola), cattle meat and milk at 0.5 ppm, and chicken meat and eggs at 0.05 ppm. No Canadian or Mexican tolerances have been established for vinclozolin residues in succulent beans, rape, canola, meat, milk, poultry, or eggs. The CODEX MRLs for canola ( rapeseed), cattle meat, cattle milk, and poultry eggs are in harmony with the proposed tolerances associated with this petition. The chicken meat MRL ( 0.05 ppm) is not in harmony with the proposed tolerance in poultry meat ( 0.1 ppm) due to recovery discrepancies with the analytical method. [ FR Doc. 03   7246 Filed 3   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0324; FRL   7282   2]

Revised Final Health Effects Test Guideline; Skin Sensitization; Notice of Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: With this notice, EPA is announcing the availability of the revised final test guideline for Series 870   Health Effects Test Guidelines, OPPTS 870.2600 Skin Sensitization. EPA has established a unified library for test guidelines issued by the Office of Prevention, Pesticides and Toxic Substances ( OPPTS) for use in testing chemical substances to develop data for submission to EPA under the Toxic Substances Control Act ( TSCA), the Federal Food, Drug, and Cosmetic Act ( FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). These test guidelines represent an Agency effort that began in 1991 to harmonize the test guidelines within OPPTS, as well as to harmonize the OPPTS test guidelines with those of the Organization for Economic Cooperation and Development ( OECD). The process for developing and amending these test guidelines includes public participation and the extensive involvement of the scientific community, as warranted, including peer review by the Scientific Advisory Panel ( SAP), the Scientific Advisory Board ( SAB) and other expert scientific organizations, as well as determination of validation status by the Interagency Coordinating Committee for Validation of Alternative Methods ( ICCVAM).

FOR FURTHER INFORMATION CONTACT: For general information contact: TSCA information contact: TSCA Hotline at TAIS/ 7408, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCA Hotline@ epa. gov. FIFRA information contact: Communications Services Branch ( 7506C), Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5017; fax number: ( 703) 305   5558. For FIFRA technical information contact: Deborah McCall, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   7109 e mail address: mccall. deborah@ epa. gov. For TSCA technical information contact: Ronald Ward, Ph. D., Risk Assessment Division ( 7403M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   8926; e mail address: ward. ron@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under TSCA, FFDCA, or FIFRA, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of This Document and Other Related Information?

A. Docket EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0324. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is VerDate Jan< 31> 2003 19: 38 Mar 25, 2003 Jkt 200001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26MRN1. SGM 26MRN1 14636 Federal Register / Vol. 68, No. 58 / Wednesday, March 26, 2003 / Notices open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805.

B. Electronic Access You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. You may also obtain copies of test guidelines from the EPA Internet Home Page at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit II. A. Once in the system, select `` search,'' then key in the appropriate docket ID number.

III. What Action is EPA Taking? EPA is announcing the availability of the revised final test guideline for Series 870   Health Effects Test Guideline, OPPTS 870.2600 Skin Sensitization. In 1996, the SAP reviewed the use of the Local Lymph Node Assay ( LLNA) as a screening method in the Agency's harmonized test guideline OPPTS 870.2600 Skin sensitization. The LLNA is a test method for assessing the potential allergic contact dermatitis ( skin sensitization) of chemicals and compounds. In January 2001, the assay was found to be scientifically valid by ICCVAM peer review ( Ref. 1) as an alternative method, where applicable, to the traditional guinea pig tests ( Guinea Pig Maximization Test ( GPMT) ( Ref. 2) and Buehler tests ( Ref. 3)) which are currently accepted by regulatory authorities. This alternative test also provides animal welfare advantages. The Agency has now revised its harmonized test guideline OPPTS 870.2600 Skin Sensitization to incorporate the LLNA for use as an alternative method for assessing skin sensitization under the appropriate circumstances. The availability of the draft revised final test guideline OPPTS 870.2600 was announced in the Federal Register on September 12, 2001 ( 66 FR 47478) ( FRL   6801   6). The draft revised guideline was reviewed by EPA's SAP in a public meeting on December 11, 2001, and recommendations of the SAP were incorporated into the revised test protocol. The guideline has been harmonized with OECD test guideline 429 Skin Sensitization: Local Lymph Node Assay which was adopted by OECD on April 24, 2002. It should be recognized that there are certain testing situations that may necessitate the use of traditional guinea pig tests. The LLNA may not be appropriate for all types of test materials, such as certain metallic compounds, high molecular weight proteins, strong dermal irritants and materials that do not sufficiently adhere to the ear for an acceptable period of time during treatment. When using the LLNA, particular care should be taken to ensure that hydrophilic materials are incorporated into a vehicle system that wets the skin and does not immediately run off. Thus, wholly aqueous vehicles or test materials and runny liquids are to be avoided. In all instances, the tester must document that appropriate techniques were used to facilitate adherence to the mouse ear for an adequate exposure duration. It may be possible to use the LLNA to test some of these materials if appropriate techniques are used to facilitate adherence. In situations for test materials where the LLNA is not applicable or may provide unreliable or problematic results, the GPMT tests are recommended. Although the LLNA, GPMT, or Buehler tests are considered to be acceptable tests, it is recognized that other tests may give useful results. If other tests are used, the investigator must provide justification/ reasoning for use of other procedures and methods and protocols must be provided. A positive and negative control group must be included in each test.

IV. Are There Any Applicable Voluntary Consensus Standards That EPA Should Consider? This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Section 12( d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA requires EPA to provide an explanation to Congress, through Office of Management and Budget ( OMB), when the Agency decides not to use available and applicable voluntary consensus standards when the NTTAA directs the Agency to do so.

V. References The following references are cited in this document. ( 1) The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/ Compounds. Interagency Coordinating Committee on the Validation of Alternative Methods ( ICCVAM), National Institutes of Environmental Health Sciences, NIH Publication No. 99   4494 ( 1999). ( Document available at http:// iccvam. niehs. nih. gov/ methods/ llnadocs/ llnarep. pdf.) ( 2) Magnusson, B. Identification of contact sensitizers by animal assay. Contact Dermatology 6: 46 ( 1980). ( 3) Buehler, L. V. Occ1usive patch method for skin sensitization in guinea pigs: the Buehler method. Food and Chemical Toxicology 32: 97101 ( 1994).

List of Subjects Environmental protection, Chemical testing, Test guideline.

Dated: March 11, 2003. Susan B. Hazen, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[ FR Doc. 03   7057 Filed 3   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7473   5]

National Electric Coil Superfund Site; Notice of Proposed Settlement AGENCY: Environmental Protection Agency. ACTION: Notice of proposed settlement.

SUMMARY: The United States Environmental Protection Agency is proposing to enter into an administrative settlement with responsible parties for response costs pursuant to section 122 of the Comprehensive Environmental Response, Compensation, and Liability Act ( CERCLA), 42 U. S. C. 9622( h)( 1) concerning the National Electric Coil Superfund Site located in Dayhoit, Harlan County, Kentucky. EPA will consider public comments on the proposed settlement for thirty ( 30) days. EPA may withdraw from or modify the VerDate Jan< 31> 2003 19: 38 Mar 25, 2003 Jkt 200001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 26MRN1. SGM 26MRN1


[Federal Register: August 20, 2009 (Volume 74, Number 160)]
[Notices]
[Page 42067-42068]
[DOCID:fr20au09-27]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-67-000]

City of Pasadena, CA; Notice of Filing

August 13, 2009.
    Take notice that on August 7, 2009, the City of Pasadena,
California (Pasadena), filed a Petition for Declaratory Order,
requesting the Commission to issue an Order to approve its revised Base
Transmission Revenue Requirement and its High Voltage Transmission
Revenue Requirement, to become effective October 1, 2009, pursuant to
Rules 205 and 207 of the Commission's Rules of Practice and Procedure,
18 CFR 385.205 and 385.207, and Sec.  26.1.1 of the California
Independent System Operator Corporation Tariff.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the

Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 8, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-19925 Filed 8-19-09; 8:45 am]

BILLING CODE 6717-01-P


CONTACT REPORT From: Dave Reeves Date of Contact: July 10, 2002 Company/ Agency: Minnesota Department of Environmental Protection Person Contacted: Dave Biel Subject: Mag Tape Info CONTACT SUMMARY: I spoke with Dave Biel of Minnesota Dept. of Environmental Protection ( DEP) this morning and he told me that the modeling protocol for 3M's Hutchinson facility had been approved. They ( DEP) had not done the modeling yet, but he thought that a copy of the protocol was or could be made available to the general public. He said he would call 3M today and see if they were OK with the details of the last two issues they had been discussing on the protocol. If OK ( i. e., " final"), Dave ( Biel) will fax or mail us a copy of the modeling protocol. The protocol addresses air toxics and not criteria pollutants  although Dave did not think there would be a significant difference.


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Rules and Regulations]
[Page 38657]
[FR Doc No: 2022-13995]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1926

Safety and Health Regulations for Construction

CFR Correction

    This rule is being published by the Office of the Federal Register
to correct an editorial or technical error that appeared in the most
recent annual revision of the Code of Federal Regulations.

0
In Title 29 of the Code of Federal Regulations, Part 1926, revised as
of July 1, 2021, in Sec.  1926.62, paragraph (d)(4)(ii) is revised to
read as follows:

Sec.  1926.62   Lead.

* * * * *
    (d) * * *
    (4) * * *
    (ii) Where the employer has previously monitored for lead exposure,
and the data were obtained within the past 12 months during work
operations conducted under workplace conditions closely resembling the
processes, type of material, control methods, work practices, and
environmental conditions used and prevailing in the employer's current
operations, the employer may rely on such earlier monitoring results to
satisfy the requirements of paragraph (d)(4)(i) of this section if the
sampling and analytical methods meet the accuracy and confidence levels
of paragraph (d)(9) of this section.
* * * * *
[FR Doc. 2022-13995 Filed 6-28-22; 8:45 am]
BILLING CODE 0099-10-P


[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Rules and Regulations]
[Page 4269]
[DOCID:fr27ja10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0605; Airspace Docket No. 09-ASO-19]

Establishment of Class E Airspace; Clayton, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: This action confirms the effective date of a direct final rule
published in the Federal Register September 14, 2009 that establishes
Class E Airspace at Heaven's Landing Airport, Clayton, GA.

DATES: Effective Date: 0901 UTC, January 27, 2010.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on September 14, 2009 (74 FR 46893),
Docket No. FAA-2009-0605; Airspace Docket 09-ASO-19. The FAA uses the
direct final rulemaking procedure for a non-controversial rule where
the FAA believes that there will be no adverse public comment. This
direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
December 17, 2009. No adverse comments were received, and thus this
notice confirms that effective date.

    Issued in College Park, Georgia, on January 14, 2010.
Myron A. Knight,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-1381 Filed 1-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 3, 2009 (Volume 74, Number 21)]
[Notices]
[Page 5968-5969]
[DOCID:fr03fe09-69]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Airports Grants Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. The FAA collects information from airport
sponsors and planning agencies in order to administer the Airports
Grants Program.

DATES: Please submit comments by April 6, 2009.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Airports Grants Program.
    Type of Request: Revision of an approved collection.
    OMB Control Number: 2120-0569.
    Forms(s): Forms 5100-100, 5100-101, 5100-108, 5100-126, 5100-127,
5370-1.
    Affected Public: A total of 1,950 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden Per Response: Approximately 8.5 hours per
response.
    Estimated Annual Burden Hours: An estimated 78,156 hours annually.
    Abstract: The FAA collects information from airport sponsors and
planning agencies in order to administer the Airports Grants Program.
Data is used to determine eligibility, ensure proper use of Federal
Funds, and ensure project accomplishments.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla

Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on January 26, 2009.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E9-2202 Filed 2-2-09; 8:45 am]

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 [Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Notices] [Page 39442] [FR Doc No: 2017-17510]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4069]

Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New

Drug Application for BAYCOL (cerivastatin sodium) Tablets, 0.05

Milligrams, 0.1 Milligrams, 0.2 Milligrams, 0.3 Milligrams, 0.4

Milligrams, and 0.8 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval

of new drug application (NDA) 020740 for BAYCOL (cerivastatin sodium)

tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8

mg, held by Bayer Healthcare Pharmaceuticals (Bayer). Bayer requested

withdrawal of this application, and has waived its opportunity for a

hearing.

DATES: Approval is withdrawn as of August 18, 2017.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of

Regulatory Policy, Center for Drug Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,

Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NDA 020740 for BAYCOL (cerivastatin sodium)

tablets, 0.05 mg, 0.1 mg, 0.2 mg, and 0.3 mg, was received on June 26,

1996, under section 505(b) of the Federal Food, Drug, and Cosmetic Act

(FD&C Act). FDA approved NDA 020740 on June 26, 1997, as safe and

effective as an adjunct to diet for the reduction of elevated total and

LDL cholesterol levels in patients with primary hypercholesterolemia

and mixed dyslipidemia (Frederickson Types IIa and IIb) when the

response to dietary restriction of saturated fat and cholesterol and

other non-pharmacological measures alone has been inadequate.

Supplemental NDAs were received by FDA on July 17, 1998, for the 0.4 mg

strength of the drug (approved on May 24, 1999) and on September 23,

1999, for the 0.8 mg strength of the drug (approved on July 21, 2000).

The most recently approved labeling (May 21, 2001) for this drug stated

that: ``BAYCOL[supreg] (cerivastatin sodium tablets) is indicated as an

adjunct to diet to reduce elevated Total-C, LDL-C, apo B, and TG and to

increase HDL-C levels in patients with primary hypercholesterolemia and

mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to

dietary restriction of saturated fat and cholesterol and other non-

pharmacological measures alone has been inadequate.''

    Over time, however, reports associating cerivastatin with

rhabdomyolysis, a potentially fatal condition involving muscle

weakness, increased. Because of these reports, Bayer withdrew BAYCOL

from the market on August 8, 2001. On January 24, 2014, Bayer wrote to

FDA asking the Agency to withdraw approval of NDA 020740 under 21 CFR

314.150(d) and waived its opportunity for a hearing.

    Accordingly, under section 505(e) of the FD&C Act (21 U.S.C.

355(e)) and section 314.150(d), approval of NDA 020740, and all

amendments and supplements thereto, is withdrawn. Distribution of

BAYCOL (cerivastatin sodium) tablets, 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg,

0.4 mg, and 0.8 mg in interstate commerce without an approved

application is illegal and subject to regulatory action (see sections

505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: August 15, 2017.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2017-17510 Filed 8-17-17; 8:45 am]

BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17610-17612]
[FR Doc No: 2021-06960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0405]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 collections related to
Medical Device Recall Authority.

DATES: Submit either electronic or written comments on the collection
of information by June 4, 2021.

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 June 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 4, 2021. 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-2018-N-0405 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Recall
Authority.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Medical Device Recall Authority--21 CFR part 810

OMB Control Number 0910-0432--Extension

    This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), mandatory medical device recall authority
provisions. Section 518(e) of the FD&C Act provides FDA with the
authority to issue an order requiring an appropriate person, including
manufacturers, importers, distributors, and retailers of a device, if
FDA finds that there is reasonable probability that the device intended
for human use would cause serious, adverse health consequences or
death, to: (1) Immediately cease distribution of such device and (2)
immediately notify health professionals and device-user facilities of
the order and to instruct such professionals and facilities to cease
use of such device.
    FDA will then provide the person named in the cease distribution
and notification order with the opportunity for an informal hearing on
whether the order should be amended to require a mandatory recall of
the device. If, after providing the opportunity for an informal
hearing, FDA determines that such an order is necessary, the Agency may
amend the order to require a mandatory recall.
    FDA issued part 810 to implement the provisions of section 518 of
the FD&C Act. The information collected under the mandatory recall
authority provisions will be used by FDA to implement mandatory
recalls.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                Collection activity--21 CFR section                     Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collections Specified in the Order--810.10(d)......................                2                1                2                8               16
Request for Regulatory Hearing--810.11(a)..........................                1                1                1                8                8
Written Request for Review--810.12(a) and (b)......................                1                1                1                8                8
Mandatory Recall Strategy--810.14..................................                2                1                2               16               32
Periodic Status Reports--810.16(a) and (b).........................                2               12               24               40              960
Termination Request--810.17(a).....................................                2                1                2                8               16
                                                                    ------------------------------------------------------------------------------------
    Total Hours....................................................  ...............  ...............  ...............  ...............            1,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                Collection activity--21 CFR section                     Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Notifications to Recipients--810.15(b)............                2                1                2                8               16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                Collection activity--21 CFR section                     Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification to Recipients--810.15(a) through (c)..................                2                1                2               12               24
Notification to Recipients; Followup--810.15(d)....................                2                1                2                4                8
Notification of Consignees by Recipients--810.15(e)................               10                1               10                1               10
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............               42
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates are based on FDA's experience with voluntary
recalls under 21 CFR part 7. FDA expects no more than two mandatory
recalls per year, as most recalls are done voluntarily.

    21 CFR 810.10(d)--Collections Specified in the Order--(Reporting)--
FDA may require the person named in the cease distribution and
notification order to submit certain information to the Agency, e.g.,
distribution information, progress reports.
    21 CFR 810.11(a)--Request for Regulatory Hearing--(Reporting)--A
request for regulatory hearing regarding the cease distribution and
notification order must be submitted in writing to FDA.
    21 CFR 810.12(a) and (b)--Written Request for Review--(Reporting)--
In lieu of requesting a regulatory hearing under Sec.  810.11, the
person named in the cease distribution and notification order may
submit a written request to FDA asking that the order be modified or
vacated. A written request for review of a cease distribution and
notification order shall identify each ground upon which the requestor
relies in asking that the order be modified or vacated, address an
appropriate cease distribution and notification strategy, and address
whether the order should be amended to require a recall of the device
that was the subject of the order and the actions required by such a
recall order.
    21 CFR 810.14--Mandatory Recall Strategy--(Reporting)--The person
named in the cease distribution and notification order or a mandatory
recall order must develop and submit a strategy to FDA for complying
with the order that is appropriate for the individual circumstances.
    21 CFR 810.15(a) through (c)--Notifications to Recipients--(Third-
Party Disclosure)--The person named in a cease distribution and
notification order or a mandatory recall order must promptly notify
each health professional, user facility, consignee, or individual of
the order.
    21 CFR 810.15(b)--Documentation of Notifications to Recipients--
(Recordkeeping)--Telephone calls or other personal contacts may be made
in addition to, but not as a substitute for, the verified written
communication, and shall be documented in an appropriate manner.
    21 CFR 810.15(d)--Notification to Recipients; Followup--(Third-
Party Disclosure)--The person named in the cease distribution and
notification order or mandatory recall order shall ensure that followup
communications are sent to all who fail to respond to the initial
communication.
    21 CFR 810.15(e)--Notification of Consignees by Recipients--(Third-
Party Disclosure)--Health professionals, device user facilities, and
consignees should immediately notify their consignees of the order.
    21 CFR 810.16(a) and (b)--Periodic Status Reports--(Reporting)--The
person named in a cease distribution and notification order or a
mandatory recall order must submit periodic status reports to FDA to
enable the Agency to assess the person's progress in complying with the
order. The frequency of such reports and the Agency official to whom
such reports must be submitted will be specified in the order.
    21 CFR 810.17(a)--Termination Request--(Reporting)--The person
named in a cease distribution and notification order or a mandatory
recall order may request termination of the order by submitting a
written request to FDA. The person submitting a request must certify
that he or she has complied in full with all the requirements of the
order and shall include a copy of the most current status report
submitted to the Agency.
    Based on a review of the information collection since our last
request for OMB approval, we have made no changes to the burden
estimate.

    Dated: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06960 Filed 4-2-21; 8:45 am]
BILLING CODE 4164-01-P