[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3451-3452]
[FR Doc No: 2023-00986]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-580, OMB Control No. 3235-0642]

Proposed Collection; Comment Request; Extension: Investment
Company Interactive Data

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Certain funds have current requirements to submit to the Commission
information included in their registration statements, or information
included in or amended by any post-effective amendments to such
registration statements, in response to certain form items in
structured data language (``Investment Company Interactive Data'').
This also includes the requirement for funds to submit interactive data
to the Commission for any form of prospectus filed pursuant to 17 CFR
230.497(c) or 17 CFR 230.497(e)

under the Securities Act of 1933 (``Securities Act'') [15 U.S.C. 77a et
seq.] that includes information in response to certain form items. This
collection of information relates to regulations and forms adopted
under the Securities Act, and the Investment Company Act of 1940
(``Investment Company Act'') [15 U.S.C. 80a-1 et seq.], that set forth
disclosure requirements for funds and other issuers.
    On October 26, 2022, the Commission adopted rule and form
amendments that require open-end management investment companies
(``open-end funds'') to transmit concise and visually engaging annual
and semi-annual reports to shareholders that highlight key information
that is particularly important for retail investors to assess and
monitor their fund investments.\1\ The Commission also adopted
amendments to Form N-1A, Form N-CSR, and rule 405 of Regulation S-T to
require certain new structured data requirements for open-end funds.\2\
Specifically, the final rule and form amendments require open-end funds
to tag their shareholder report contents using Inline eXtensible
Business Reporting Language or ``Inline XBRL.'' These requirements will
make open-end funds' shareholder report disclosure more readily
available and easily accessible for aggregation, comparison, filtering,
and other analysis.
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    \1\ See Tailored Shareholder Reports for Mutual Funds and
Exchange-Traded Funds; Fee Information in Investment Company
Advertisements, Investment Company Act Release No. 34731 (Oct. 26,
2022) (``Shareholder Reports Adopting Release'').
    \2\ See Shareholder Reports Adopting Release at section II.H.
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    The Commission estimates that the total current annual hour burden
associated with the Investment Company Interactive Data requirements is
approximately 252,684 hours. Based on estimates of 11,840 open-end
funds, each incurring 6 hours on average annually to tag their
shareholder reports using Inline XBRL, the Commission estimates that,
in the aggregate, funds will incur an additional 71,040 annual burden
hours. The Commission therefore estimates that, in the aggregate,
Investment Company Interactive Data requirements will result in
approximately 323,724 annual burden hours (252,684 currently-estimated
annual burden hours + 71,040 additional estimated annual burden hours).
    The Commission estimates that the current average cost burden
associated with the Investment Company Interactive Data requirements is
approximately $15,449,450 per year. Based on the estimate of 11,840
open-end funds, each incurring approximately $50 additional annual
external cost associated with tagging their shareholder reports using
Inline XBRL, the Commission estimates that, in the aggregate, funds
will incur an additional $592,000 in annual external costs. The
Commission therefore estimates that, in the aggregate, Investment
Company Interactive Data requirements will result in approximately
$16,041,450 in external costs ($15,449,450 in currently-estimated
external costs + $592,000 in additional external costs).
    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even representative survey or study of the costs of Commission rules
and forms.
    The collection of information under the Investment Company
Interactive Data requirements is mandatory for all funds. Responses to
the disclosure requirements will not be kept confidential. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by March 20, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: January 13, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-00986 Filed 1-18-23; 8:45 am]
BILLING CODE 8011-01-P


Page 1 Memorandum To: Debbi Hart and Lynne Tudor, U. S. EPA From: Dave Cacela and Liz Strange, Stratus Consulting Inc.

Date: 2/ 13/ 2004 Subject: Summary of Peer Reviews of I& E Methods Chapter A5 1. Introduction Chapter A5 describes the methods used by EPA to evaluate I& E. Professor Gary Grossman, Professor Pete Raimondi, and Dr. Shuter are fisheries scientists who were contracted by EPA ( through Versar, Inc.) to critique the chapter with respect to several specific topic areas. This memorandum summarizes the reviewers' main comments and provides responses to those comments. Some of the reviewers' criticisms are no longer pertinent to the rulemaking because EPA has made changes to Chapter A5 since the time that the three reviews were conducted.

2. Critique by Professor Gary Grossman A criticism expressed by Professor Grossman concerns the possibility of incorporating stochasticity in the survival modeling that informs the estimation of foregone fishery yield. Professor Grossman suggests that the assessment would be improved if environmental stochasticity was explicitly included in the model. He does not suggest exactly how it should be included, so it is not possible to comment on the feasibility or utility of adding a particular kind of stochasticity. EPA acknowledges that fish populations are affected by ecological processes that cannot be well described except in stochastic terms. However, EPA maintains that an adequate assessment of the economic benefits of the 316( b) rulemaking does not require a highly detailed, highly realistic ecological model. The practical requirements of developing models along the lines suggested by Professor Grossman are quite substantial, even for modeling the dynamics of a single fish stock. Inclusion of stochasticity in a model does not automatically make the model better or more useful unless the nature of the stochasticity is correctly formulated. The limitations in this regard are not simply computing power, as Professor Grossman suggests, but sufficient understanding of the systems in question. The benefits assessment is addressed at estimating effects on hundreds of stocks nationwide and inclusion of the stochastic details specific to each of these stocks is not a realistic goal. Stratus Consulting 2/ 13/ 04 Page 2 Although EPA has not included stochasticity within the I& E model itself, EPA has employed stochasticity in a parallel investigation of uncertainty associated with the I& E modeling procedure ( see Chapter A6 of the Regional Analysis Document). The investigation uses Monte Carlo methods to handle plausible degrees of uncertainty associated with all of the numerous parameters in the model. The investigation is not complete, due in part to uncertainty about selection of probability distributions.

Professor Grossman states that the absence of reporting about stock sizes is a problem. The concern is apparently motivated by a belief that estimating population impacts is the objective of the assessment, but that is not the case. EPA's core I& E modeling approach is to use a static set of population parameters to generate simple point estimates of foregone yield. EPA has intentionally generated benefits estimates that are linked directly to the estimates of I& E losses, not indirectly through estimates of population level impacts. This approach is intended to provide reasonable estimates of the general magnitude of losses associated with I& E mortality, and not to develop realistic population dynamic models. Projections of future fish population dynamics is simply out of the scope of the benefits assessment.

Another criticism expressed by Professor Grossman concerns the regional extrapolation of loss estimates at model facilities to other facilities. Professor Grossman indicates that extrapolations are invalid unless conditions at unmodeled facilities are identical to conditions at model facilities. EPA acknowledges that the extrapolations introduce additional uncertainty into the aggregate estimates. However, EPA maintains that this is unavoidable unless every in scope facility were modeled independently. In order to avoid the most significant sources of bias, EPA applied extrapolations within particular regions prior to aggregation on a national scale.

Professor Grossman expresses valid concerns about the methods used to generate annualized I& E loss estimates at individual model facilities. EPA acknowledges that numerous facility specific details, including details about the I& E sampling programs and regional ecological conditions, affect the validity of the annualized loss estimates. However, EPA's benefits assessment did not include development of the original I& E monitoring procedures. EPA relied upon the loss estimates as reported by the facilities, based on the premise that the original investigators had the necessary understanding of the facility and the local ecological conditions to develop appropriate sampling procedures and interpretations of the I& E data.

Professor Grossman questions EPA's treatment of I& E losses with respect the presence of older fish (> 1 year old) among the I& E losses. This concern has been raised by other commenters, and EPA has revised the modeling procedures by eliminating the assumption that impinged fish are all age 1. The revised procedure uses an assumption that impinged fish include individuals ranging from age 0 to age 5. Stratus Consulting 2/ 13/ 04 Page 3 3. Critique by Professor Pete Raimondi Professor Raimondi has criticized EPA's model in very general terms that relate to his beliefs that ( a) the benefits assessment has too much of a " fisheries dependent mindset" and a " fisheries bias," and ( b) the correct approach to the assessment employs an empirical transport model ( ETM), rather than the foregone yield model that EPA used.

EPA acknowledges that the benefits assessment focuses on foregone use values of fish killed by I& E. Professor Raimondi indicates that EPA has ignored values associated with " ecosystem function." EPA interprets this class of values to be among those commonly known as non use values, which include a variety of other societal values in addition to roles in ecosystem functioning. EPA has had difficulty incorporating non use values into the assessment due to a lack of relevant information about how to monetize the non use values of I& E losses.

Despite Professor Raimondi's claim that EPA's approach is " at least one generation behind" current I& E assessment methods, EPA disagrees with his assertion that ETM is a preferable method for conducting the benefits assessment. The ETM method enjoys certain aspects of ecological realism and significance for highly site specific ecological assessments, but it is not well suited to the purpose of the 316( b) national benefits assessment. The advantages of ETM that Professor Raimondi alleges have no apparent bearing on the benefits assessment because the results of an ETM assessment, as Professor Raimondi spells out, are in terms of foregone equivalent reproductive effort expressed as acreage, mileage, or a proportion of the areal extent of spawning for fishes exposed to I& E at a particular facility. EPA maintains that losses expressed in this manner are much less amenable to monetization than the direct approach to estimate foregone yield. Moreover, implementation of an ETM is a highly site specific exercise that requires intimate knowledge of both ( a) the hydrology of a particular system, and ( b) the actual spawning habits of every species exposed to I& E. The large information requirements of ETM modeling combined with the off point nature of the results of the modeling are clear reasons why EPA did not elect to use ETM modeling in the assessment.

4. Critique by Dr. Shuter Dr. Shuter's comments were generally favorable with respect to the appropriateness of EPA's modeling. EPA agrees with Dr. Shuter's suggestion that the chapter would benefit from a clearer statement about the objectives of the modeling and expectations about how the results of the model can be interpreted, and revised the chapter accordingly. A large part of his criticisms Stratus Consulting 2/ 13/ 04 Page 4 concern the actual structure of the chapter and the fact that a number of relevant facts required to implement the model are physically located in inconvenient places, such as in an unattached appendix. EPA believes that some of the practical difficulties noted by Dr. Shuter would be absent for readers that have the complete assessment in hand, rather than simply Chapter A5 in isolation.

Another general concern expressed by Dr. Shuter concerns the level of detail provided about the modeling procedures, which he perceived as being too general for rigorous assessment. EPA has revised Chapter A5 in response to these comments, and believes that the current version of the chapter is now more complete.

Dr. Shuter expresses concern about how life history parameters ( e. g., survival rates) were identified and/ or generated. The majority of the survival rates that EPA employed were derived from literature sources that are fully referenced in the assessment report. EPA acknowledges that there are numerous difficulties associated with applying survival rates reported in published records to novel situations, some of which may be quite influential in the benefits assessment. However, EPA believes that it has been completely transparent in this regard by publishing all of the values that were used and their original sources. Part of Dr. Shuter's concern in this regard may relate to the wording used in earlier versions of the chapter that unfortunately overstated the role of the " Fa method" in identifying survival rates. This wording made it appear that the Fa method was used as a primary tool and that reference values for the majority of survival rates could not be identified. In fact, EPA identified reference values for the vast majority of survival rates employed, and used the Fa method only as a last resort. EPA acknowledges that substantial uncertainties remain about proper survival rates ( with respect to both M and F) and that uncertainty in these values causes significant portion of the uncertainty in the benefits assessment.

Dr. Shuter raises some interesting conceptual questions about the relationships among I& E losses, the mortality rates M and F, and the possible decomposition of M into components that explicitly describe M attributable to I& E. Dr. Shuter also identifies relationships between interpretation of these concepts and EPA's use of static rather than dynamic values for these parameters. In particular, Dr. Shuter questions the implications of a preconceived notion that the relative magnitude of I& E mortality is small compared to other forces of mortality. EPA acknowledges that these are valid concerns. However, EPA's statements that I& E mortality is minor are not intended to be a value judgement, nor a presumption that they can be ignored out of hand. Rather, they are intended to indicate that, as a general rule, I& E losses are not expected to be dominant driving forces in the dynamics of most populations. If this presumption is valid, then the commonly perceived need to proceed directly to sophisticated, population specific fisheries models that include compensation and other kinds of dynamics may be discounted. EPA's philosophy in this regard is that it is legitimate to use the direct foregone yield approach because Stratus Consulting 2/ 13/ 04 Page 5 these losses are " minor" enough to be considered simply as incremental differences that occur concurrently and additively with other more dramatic forces that drive large scale population changes. Thus, conceiving of these losses as " relatively minor" refers only to importance within the suite of other population drivers, but not necessarily to importance in economic terms. The value of fisheries on a national scale is tremendous, so a ( possibly) " minor" reduction of that resource could actually be very large in absolute terms.

Dr. Shuter noted some inconsistencies in notation with regard to the terms " ages" and stages." EPA regrets the inconsistency and possible confusion resulting from it. In fact, EPA's models are best described as " stage specific" throughout the assessment. The confusion arose because the actual stages that EPA employed correspond directly to " ages" for all fish age 1 and older, i. e., adulthood was not modeled as a single stage but as multiple stages corresponding to years.


[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2879-2883]
[FR Doc No: 2019-01561]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0407]

Pilot Project Program Under the Drug Supply Chain Security Act;
Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the start of the Pilot Project Program Under the Drug Supply Chain
Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project
Program is intended to assist FDA and members of the pharmaceutical
distribution supply chain in the development of the electronic,
interoperable system that will identify and trace certain prescription
drugs as they are distributed within the United States. Under this
program, FDA will work with stakeholders to establish one or more pilot
projects to explore and evaluate methods to enhance the safety and
security of the pharmaceutical distribution supply chain. Participation
in the DSCSA Pilot Project Program is voluntary and will be open to
pharmaceutical distribution supply chain members to apply to the
program. FDA will ensure that participation reflects the diversity of
the supply chain, including large and small entities from all industry
sectors. This notice establishes the DSCSA Pilot Project Program and
includes instructions for submitting a request to participate and
expectations for program participants.

DATES: FDA will be accepting applications for participation in the
DSCSA Pilot Project Program beginning February 8, 2019 and continuing
through March 11, 2019. The duration of the DSCSA Pilot Project Program
will depend on the pilot project(s) accepted into the program and when
the projects are completed.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system by November
27, 2023, that will identify and trace certain prescription drugs as
they are distributed within the United States. Section 202 of the DSCSA
added sections 581 and 582 to the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee and 360eee-1, respectively). Under section
582(j) of the FD&C Act, FDA is required to establish one or more pilot
projects, in coordination with authorized manufacturers, repackagers,
wholesale distributors, and dispensers, to explore and evaluate methods
to enhance the safety and security of the pharmaceutical distribution
supply chain.
    FDA is establishing the DSCSA Pilot Project Program to implement
section 582(j) of the FD&C Act. This program is intended to assist FDA
and members of the pharmaceutical distribution supply chain in the
development of the interoperable electronic system to be established by
2023. The 2023 system has the potential to reduce diversion of drugs
distributed domestically as well as help deter counterfeit drugs from
entering the supply chain. The pilot program will be designed to
explore issues related to utilizing the product identifier for product
tracing, improving the technical capabilities of the supply chain,
identifying the system attributes that are necessary to implement the
requirements established under the DSCSA, and any other issues
identified by FDA (see section 582(j)(2)(B) of the FD&C Act).
    Particular program goals include: (1) Identifying the system
attributes needed to implement the requirements of section 582 of the
FD&C Act, particularly the requirement to utilize a product identifier
for product tracing and verification purposes and (2) assessing the
ability of supply chain members to satisfy the requirements of section
582 of the FD&C Act; identify, manage, and prevent the distribution of
suspect and illegitimate products as defined in section 581(21) and
581(8) of the FD&C Act, respectively, and exchange product tracing
information across the pharmaceutical distribution supply chain in an
electronic and interoperable manner. FDA plans to coordinate with
stakeholders to ensure that pilot projects reflect the diversity of the
pharmaceutical distribution supply chain, including large and small
entities from all industry sectors. The DSCSA Pilot Project Program is
intended to help identify and evaluate the most efficient processes
and/or systems to operationalize supply chain security requirements.

II. The DSCSA Pilot Project Program

    FDA is seeking pilot project participants from the pharmaceutical
distribution supply chain (e.g., authorized manufacturers, repackagers,
wholesale distributors, and dispensers) and other stakeholders. FDA
expects potential participants to propose the design and execution of
their pilot project in their submission to FDA; however, FDA intends to
meet with selected pilot project participants to ensure that the
learnings from the pilot project(s) will be complementary in informing
all stakeholders in the development of the electronic, interoperable
system that will go into effect in 2023. FDA encourages potential
participants to focus their proposed pilot project(s) on the DSCSA
requirements related to the interoperable, electronic tracing of
products at the package level. Specifically, the pilot project(s)
should focus on the enhanced requirements for package-level tracing and
verification that go into effect in 2023. Such pilot projects will
likely be more useful than pilot projects dedicated to lot-level
tracing. If there is an adequate number of pilot project submissions,
FDA may establish more than one pilot project to accomplish the goals
of the DSCSA Pilot Project Program.

A. Products Eligibility

    Pilot projects should focus on applicable requirements to any
prescription drug that is a ``product'' within the meaning of section
581(13) of the FD&C Act. FDA anticipates that packages and homogenous
cases of product that are part of a pilot project will generally bear a
``product identifier'' as described in sections 581(14) and 582(a)(9)
of the FD&C Act. FDA may also consider proposed pilot projects
involving product that may be subject to a waiver, exception or
exemption of certain DSCSA requirements, products that are
grandfathered, in addition to products that are outside the scope of
section 581(13) of the FD&C Act (e.g., over-the-counter medicines) if
such project(s) could further the objectives of the DSCSA Pilot Project
Program.

B. Potential Issues To Examine and Evaluation Methods To Use in Pilot
Projects

    On April 5-6, 2016, FDA held a public workshop entitled ``Proposed
Pilot Project(s) Under the Drug Supply Chain Security Act (DSCSA).''
This public workshop provided a forum for members of the pharmaceutical
distribution supply chain to discuss the design objectives of pilot
projects established by FDA under section 582(j) of the FD&C Act. Based
on the information gathered at that workshop and from the comments
submitted to the public docket for the workshop (Docket No. FDA-2016-N-
0407), FDA identified several potential issues to examine, and
evaluation methods to use, in pilot projects established under the
DSCSA Pilot Project Program. These potential

issues and evaluation methods are summarized in table 1. This table is
intended only to assist in the design of potential pilot projects; it
does not represent FDA's views or policies regarding the issues
described in the table. For ease of reference, the potential issues to
examine and evaluation methods have been grouped by focus areas for the
pilot projects.

  Table 1--Potential Issues To Examine and Evaluation Methods To Use in
                             Pilot Projects
------------------------------------------------------------------------
                               Potential issues to  Potential evaluation
  Pilot project focus area           examine               methods
------------------------------------------------------------------------
Product Identifier..........   Processes     Impacts of
                               related to the        different
                               requirement for       representations of
                               manufacturers to      the product
                               affix or imprint a    identifier on
                               product identifier    systems or
                               to each package and   processes:
                               homogenous case of   --Number of errors.
                               product intended to  --Time to process.
                               be introduced in a   --Time to reconcile
                               transaction into      differences.
                               commerce.
                               Methods
                               used to issue and
                               manage serial
                               numbers (e.g.,
                               including a
                               contract
                               manufacturer's role
                               if applicable or
                               how a repackager
                               associates its
                               product identifier
                               with the product
                               identifier assigned
                               by the original
                               manufacturer).
                               Different
                               representations for
                               the product
                               identifier (e.g.,
                               different formats
                               of the National
                               Drug Code or serial
                               number).
Barcodes....................   Readability   Barcode
                               of a barcode either   read error rates:
                               printed or affixed   --Number of items
                               to product,           unnecessarily
                               including impact of   quarantined or held
                               environmental and     up.
                               human factors.       --Time and resource
                               Application   impacts.
                               of linear barcode
                               and 2D barcode on
                               product.

                               Distinguishing
                               which barcode to
                               read/use.
Interoperability............   Process and   For both
                               technical             decentralized and
                               challenges due to a   centralized models,
                               variety of            time implications:
                               potential solutions  --To investigate
                               (e.g., type of        suspect and
                               database used and     illegitimate
                               system architecture   products.
                               for exchanging       --For notifications
                               information among     required within the
                               trading partners).    statutory
                               Maintaining   timelines.
                               the integrity of     --Related to scaling
                               information           up from pilot to
                               contained in the      full production.
                               barcode of            Product
                               serialized product    tracing information
                               throughout the        (across multiple
                               distribution supply   partners):
                               chain (e.g., a       --Capability to
                               trading partner       retrieve the
                               goes out of           information.
                               business or one      --Accuracy of the
                               acquires another      information (within
                               business).            and between
                               Different     systems).
                               methods for           Security
                               exchanging            and access:
                               information (e.g.,   --Evaluate and
                               the use of            document access
                               Electronic Data       levels for trading
                               Interchange,          partners.
                               Electronic Product
                               Code Information
                               Services, and other
                               solutions
                               separately).
Data/Database/System Issues.   Data          System
                               quality from          Performance and
                               beginning to end of   Effectiveness:
                               the product          --Time to access and
                               lifecycle and vice    use product tracing
                               versa.                information once
                               System        that data is
                               performance when      received into a
                               full or partially     system.
                               loaded with data.    --Quality of product
                               Data format   tracing
                               or processes for      information.
                               data transfer:.      --Number of breaches
                              --Use of technical     to system.
                               standards for        --Number of attempts
                               defining data         to breach the
                               attributes to         system that were
                               enable                prevented or
                               interoperable         minimized.
                               transfers.            Data and
                              --Methods to handle    product flow.
                               the ``master data''  --Number of
                               (product-specific     unsuccessful
                               data) and             attempts to access
                               transaction data      data and
                               separately to         operational
                               minimize ``master     impacts.
                               data'' redundancy.   --Number of system
                               Integration   interactions within
                               into individual/      one, and amongst
                               company data          multiple, trading
                               systems.              partners.
                               Control and  --Time and resource
                               access to data by     changes on
                               trading partners,     operations when
                               FDA, or other         data and product
                               federal or state      not moving at same
                               officials (data       time (e.g., product
                               governance).          arrives before data
                               Ability of    arrives).
                               the system to        --Time for location/
                               record product        ownership/status
                               status (e.g., to      changes to be
                               indicate expired,     reflected in the
                               illegitimate, in      system.
                               error, quarantined)  --Time of product
                               at all packaging      flow delays and
                               levels.               associated costs
                                                     due to system or
                                                     data problems.
Aggregation/Disaggregation..   Multiple      Number of
                               levels of adoption    system and product
                               of inference, by      interactions within
                               different trading     one, and amongst
                               partners. Impact of   multiple, trading
                               inference gaps,       partners.
                               changes or errors     Time
                               in data,              required to conduct
                               particularly          aggregate/
                               downstream when       disaggregate
                               searching or          operations and
                               examining the data;   transactions.
                               how can errors be     Accuracy of
                               corrected.            aggregation data
                                                     (measure error
                                                     counts).
                                                     Time to
                                                     gather aggregation/
                                                     disaggregation data
                                                     for investigations
                                                     and notifications.
                                                     Time to
                                                     resolve errors in
                                                     data.

Verification/Notification...   Process for   Response
                               investigation of      times: Current vs.
                               suspect or            future process.
                               illegitimate          Time needed
                               product, including    to obtain product
                               any communication     tracing information
                               or coordination:.     to respond to a
                              --Making and           request for
                               responding to         verification.
                               verification          Time needed
                               requests.             to make, respond
                              --Making, responding   to, or terminate a
                               to, and termination   notification.
                               of notifications.     Time to
                              --Responding to        gather product
                               requests for          tracing information
                               information.          to support an
                              --Testing boundaries   investigation for a
                               of the system.        suspect or
                                                     illegitimate
                                                     product, or a
                                                     recall.
                                                     Percentage
                                                     of items that are
                                                     successfully
                                                     verified vs. those
                                                     that were targeted
                                                     for verification.
                                                     Number of
                                                     connections/queries
                                                     needed to gather
                                                     product tracing
                                                     information in
                                                     response to a
                                                     verification or
                                                     notification
                                                     request.
Exception Handling/Errors/     Identify      Percent of
 Inconsistencies.              `honest errors'       errors detected:
                               (e.g., over/under     Compare exceptions
                               shipments, clerical   introduced vs.
                               errors, or            exceptions
                               aggregation errors).  detected:
                               Correcting   --Identify the first
                               `honest errors'.      step in the process
                                                     where an error is
                                                     detected.
                                                     Number of
                                                     new or changed
                                                     processes needed to
                                                     accomplish DSCSA
                                                     goals:
                                                    --Time and resource
                                                     impacts.
                                                     `Honest
                                                     Errors':
                                                    --Number of items
                                                     unnecessarily
                                                     quarantined and
                                                     held up.
                                                    --Time required to
                                                     detect and correct
                                                     errors.
                                                    --Impact on trading
                                                     partners to correct
                                                     errors.
                                                     Barcode
                                                     read error rates:
                                                    --Number of items
                                                     unnecessarily
                                                     quarantined or held
                                                     up.
                                                    --Time and resource
                                                     impacts.
Special Scenarios...........   Situations    Error rates
                               when data and         for special
                               product do not move   processes:
                               together.            --Number of items
                               Situations    unnecessarily
                               when serialized       quarantined or held
                               product are sold      up.
                               and distributed      --Time and resource
                               along with non-       impacts.
                               serialized product.   Accuracy of
                                                     linkage between
                                                     original
                                                     manufacturer
                                                     product identifier
                                                     and repackager-
                                                     issued product
                                                     identifier.
------------------------------------------------------------------------

    In addition to the information in table 1, workshop participants
and comments submitted to the public docket recommended factors that
FDA should take into consideration when establishing pilot projects.
The recommended factors include the extent to which the pilot projects:

 Represent the mix of products and levels of packaging in the
supply chain
 Include a diverse set of supply chain stakeholders (types and
sizes) and transaction types
 Use adaptive design to make the pilot projects more efficient.
 Target known weaknesses in the supply chain
 Can be completed in such a time frame to provide useful
information for trading partners
 Evaluate human factors that could present implementation
challenges
 Simulate illegitimate products/transactions to test a process
or system
 Document costs to implement, use, and maintain piloted
solutions

    Although the Agency intends to take these factors into
consideration when establishing pilot projects, FDA also recognizes
that a single pilot project is unlikely to satisfy every factor.
Accordingly, requests to establish a pilot project need not satisfy all
the factors listed in this document.

C. Instructions for Submitting a Request To Participate in the DSCSA
Pilot Project Program

    Stakeholders interested in participating in the DSCSA Pilot Project
Program may submit a request to participate by email to
<EMAIL_ADDRESS>For a group of entities that partner to
participate in a pilot project, only one submission and one point-of-
contact for the proposed pilot project should be provided in the
request to participate. Requests to participate may also consider other
ideas for a pilot project that are not included in this notice.

D. Submission Content for Requesting To Participate in the DSCSA Pilot
Project Program

    The following information should be included in the request:

 Contact information for the submitter or point of contact, if
different from the submitter (name, mailing address, phone number,
email address)
 Names of all partnering entities that would participate in the
pilot project (name of company and name of company representative)
 Type(s) of each partnering entity participating in the pilot
project (e.g., manufacturer, repackagers, wholesale distributor,
dispenser, third-party logistics provider, solution provider, trade
association, etc.); Partnering entities may include authorized trading
partners or other supply chain stakeholders
 Number of employees for each partnering entity to reflect
company size
 Proposed start and finish dates of the pilot project
 Commitment to start the pilot project within 4 months of
receiving a letter of acceptance from FDA
 Product(s) that will be used in the pilot project
 Location(s) where pilot project will be performed (facility
address)

 Description of the proposed pilot project, including, but not
limited to, the goals, objectives, processes that will be studied, and
evaluation methods

E. Initiation and Duration of Pilot Projects

    The selected participants should be ready to start their pilot
project within 4 months of receiving a letter of acceptance from FDA
into the program. The duration of a pilot project should not exceed 6
months. FDA may consider a pilot project with a later start date or
longer duration depending on the proposed goal(s) and objective(s).
Each pilot project is expected to be completed within the proposed
duration time period. This time period does not include an additional
30 days for completion of a final report (see Section II.G. Reports).

F. Participation in Pilot Projects

    Each participant that is selected into the program will be
responsible for conducting its pilot project. A group of entities
(e.g., members of the pharmaceutical distribution supply chain or other
stakeholders, including trade associations) that partners to conduct a
pilot project will be considered a single participant for purposes of
the DSCSA Pilot Project Program. The participant will be responsible
for the funding and resources necessary to conduct the pilot project,
and for determining each partner's role and responsibility in its pilot
project.
    Prior to launch of a pilot project, FDA intends to hold a design
strategy meeting with the selected pilot participant(s) to review the
goal(s) and objective(s)s for the pilot project and discuss the project
plans and other pertinent details. FDA also expects pilot project
participants to submit reports on the progress of their pilot projects
to FDA (see Section II.G. Reports). Participants should evaluate their
pilot projects using the evaluation methods they identified during the
pilot project design process.

G. Reports

    Each pilot project is expected to be completed within the proposed
duration time period, and FDA asks that all participants submit
periodic progress reports to FDA while the pilot project is being
conducted, in addition to submitting a final report after completing
the pilot project. These reports will provide insight into the systems
and process needed to comply with certain DSCSA requirements for
enhanced drug distribution security.
1. Progress Report(s)
    Each pilot project program participant is expected to provide
reports on the progress of its pilot project to FDA. The progress
reports are intended to capture the ongoing work during the pilot
project, including but not limited to, status or results, changes,
challenges, and/or lessons learned. FDA will work with participants to
develop an appropriate schedule for the submission of progress reports
based on the design and duration of the pilot project. Because the
duration of a pilot project should not exceed 6 months, the frequency
of progress reports will vary based on the length of the individual
pilot project. Pilot projects of relatively shorter duration may result
in shorter time intervals between progress reports. For example, FDA
may ask for monthly progress reports for a 6-month pilot project,
however for a 1-month pilot project, FDA may ask for weekly progress
reports.
2. Final Report
    Within 30 to 45 business days of completing a pilot project, each
participant is expected to provide a final report to FDA that captures
the description, objectives, methods, evaluation, costs and key
findings, and lessons learned from the project. Timely completion of
pilot projects and the final report will support FDA's DSCSA
implementation, including the statutory requirements under section
582(j) of the FD&C Act to consider information from pilot projects in
the development of guidances for unit-level tracing and standards for
the interoperable data exchange in section 582(h)(3) and (4) of the
FD&C Act. FDA may also request that the participants meet with the
Agency upon the completion of their pilot project or the final report.

H. Final DSCSA Pilot Project Program Report

    To ensure that all supply chain members benefit from the
information generated by the DSCSA Pilot Project Program, FDA intends
to make the following information about each pilot project of the
program available to the public in a final program report: (1) The
names and industry sector(s) of the pilot project participant(s); (2)
the pilot project's objectives and evaluation methods; (3) the duration
of the pilot project; and (4) the key findings and lessons learned from
the pilot project. FDA intends to post the information related to the
DSCSA Pilot Project Program and the final program report on FDA's
website.

I. Recordkeeping

    Any records generated by a participant while conducting a pilot
project should be maintained in accordance with the participant's
normal recordkeeping practices. For pilot projects that involve
partnering entities, the partnering entities should decide who is
responsible for the records generated in the course of conducting the
pilot project. FDA recommends that participants maintain the progress
reports and final report for its pilot project for at least 1 year
after completion of the pilot project.

III. Paperwork Reduction Act of 1995

    This notice contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this notice was approved under OMB control
number 0910-0859.

    Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01561 Filed 2-7-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65217-65219]
[FR Doc No: 2019-25790]

=======================================================================
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UNIFIED CARRIER REGISTRATION PLAN

Sunshine Act Meeting Notice; Unified Carrier Registration Plan
Board of Directors Meeting

TIME AND DATE: December 5, 2019, from Noon to 3:00 p.m., Eastern time.

PLACE:  This meeting will be accessible via conference call. Any
interested person may call 1-866-210-1669, passcode 5253902# to
participate in the meeting.

STATUS: This meeting will be open to the public.

MATTERS TO BE CONSIDERED:  The Unified Carrier Registration Plan Board
of Directors (the ``Board'') will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement. The
subject matter of the meeting will include:

Agenda

Open to the Public

I. Welcome and Call to Order--UCR Board Chair

    The UCR Board Chair will welcome attendees, call the meeting to
order, call

roll for the Board, and facilitate self-introductions.

II. Verification of Meeting Notice--UCR Executive Director

    The UCR Executive Director will verify the publication of the
meeting notice on the UCR website and in the Federal Register.

III. Review and Approval of Board Agenda and Setting of Ground Rules--
UCR Board Chair

    For Discussion and Possible Action
    Agenda will be reviewed and the Board will consider adoption.
    Ground Rules
[rtarr8] Board action only to be taken in designated areas on agenda
[rtarr8] Please MUTE your phone
[rtarr8] Please do NOT place the call on HOLD

IV. Approval of Minutes of the October 17, 2019 UCR Board Meeting--UCR
Executive Director

    For Discussion and Possible Action
     Minutes of the October 17, 2019 Board meeting will be
reviewed. The Board will consider action to approve.

V. Report of FMCSA--FMCSA Representative

    FMCSA will provide a report on any relevant activity or rulemaking,
including any pending appointments, as well as any update available
regarding a final rulemaking on 2020 UCR fees.

VI. UCR/FMCSA Memorandum of Understanding--Chief Legal Officer

    The Chief Legal Officer will report on the status of efforts to
renew the UCR/FMCSA memorandum of understanding and answer questions.

VII. Proposed Written Information Security Policy--Chief Legal Officer

    For Discussion and Possible Action
    A revised draft of a proposed policy to ensure the security,
confidentiality, integrity, and availability of personal and other
sensitive information collected, created, used, and maintained by the
UCR, will be reviewed. The Board may act to adopt the proposed policy.

VIII. Proposed Incident Response Action Plan--Chief Legal Officer

    For Discussion and Possible Action
    A revised draft of a proposed policy to provide a structured and
systematic incident response process for all information security
incidents that affect any of the UCR's information technology systems,
network, or data, including the UCR's data held or IT services provided
by third-party vendors or other service providers, will be reviewed.
The Board may act to adopt the proposed policy.

IX. Data Event Update--Chief Legal Officer

    The Chief Legal Officer will provide an update to the Board on the
action items approved at its August 1, 2019 meeting related to the
March 2019 data event.

X. Subcommittee Reports
Audit Subcommittee--Audit Subcommittee Chair
A. Report from States Delinquent on 2018 Carrier Audits

    The UCR Board will hear from representatives in the two states that
have not submitted an annual carrier audit report for the 2018
Registration Year as required by the UCR Agreement. These two states
will address their reasons for being delinquent, as well as their
corrective action plan, including timelines, for attaining compliance.

    [ssquf] Idaho
    [ssquf] Illinois

B. Reminder to State Auditors
    Remind state auditors that they can collect UCR registrations for
both 2018 and 2019 through December 31, 2019, as part of their active
investigation. This applies to any of the following scenarios:

[ssquf] MCS-150 Retreats
[ssquf] FARs
[ssquf] If the audit indicates any of the following:
     Intrastate motor carriers with a current inspection with
interstate activity.
     Intrastate motor carriers with an active MC number.
     Intrastate motor carriers with an accident in interstate
commerce.
     Inactive interstate motor carriers with a current
inspection.

C. Focused Anomaly Reviews (FARs)

     Currently states have closed approximately 55% of their
FARs.
     DSL is assigning FARs as they are discovered, continue to
monitor.

D. MCS-150 Retreats

     You must work these retreats through the National
Registration System (NRS).
     The system assigns these retreats as they are discovered,
continue to monitor.

E. Annual State Reports

     Currently, Section #19 of the Procedures Manual requires
the states to perform their MCS-150 retreat audits in the NRS.
     FARs are in a separate database administered by the UCR
Consultant and reviewed by the Audit Chair, these reports are monitored
daily.
     Since there is no report to submit, we should update the
Audit Procedures to simply have the state reports final on June 1st of
each year.
Education and Training Subcommittee--Operations Manager and Executive
Director
    An update will be given to the Board regarding the development of
three training modules, UCR 101, Enforcement, and the National
Registration System.

XI. Updates Concerning UCR Legislation--UCR Board Chair

    The UCR Board Chair will call for any updates regarding UCR
Legislation since the last Board meeting.

XII. Proposed Board Subcommittee Policy--UCR Administrator

    For Discussion and Possible Action
    A revised draft of a proposed policy to establish criteria for
individuals serving on UCR Board Subcommittees, as well as the
composition of the Subcommittees, will be reviewed. The Board may act
to adopt the proposed policy. The Board Chair will also list
appointments made to leadership posts of various Subcommittees.

XIII. Possible Revisions to 2020 Budget--UCR Administrator

    For Discussion and Possible Action
    The Depository Manager will lead a discussion concerning the need
for revisions to the budget for 2020. The Board may take action to
adopt the suggested revisions to the budget.

XIV. Proposed Calendar for 2020 UCR Meetings--UCR Executive Director

    For Discussion and Possible Action
    The Board will review a revised calendar of proposed meetings
(Board and Subcommittees) for 2020. The Board may act to adopt the
calendar for 2020.

XV. Contractor Reports--UCR Executive Director
     UCR Executive Director

    The Executive Director will provide a report covering recent
activity for the UCR Program.

     UCR Administrator (Kellen)

    The UCR Administrator will provide their management report covering
recent activity for the Depository, Operations, and Communications.

     DSL Transportation Services, Inc.

    DSL will report on the latest data on state collections based on
reporting from the Focused Anomalies Review (FARs) program.

     Seikosoft

    Seikosoft will provide an update on recent/new activity related to
the National Registration System.

XVI. Other Business--UCR Board Chair

    The UCR Board Chair will call for any business, old or new, from
the floor.

XVII. Adjournment--UCR Board Chair

    The UCR Board Chair will adjourn the meeting.
    This agenda will be available no later than 5:00 p.m. Eastern time,
November 25, 2019 at: https://plan.ucr.gov.

CONTACT PERSON FOR MORE INFORMATION: Elizabeth Leaman, Chair, Unified
Carrier Registration Plan Board of Directors,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Alex B. Leath,
Chief Legal Officer, Unified Carrier Registration Plan.
[FR Doc. 2019-25790 Filed 11-22-19; 4:15 pm]
 BILLING CODE 4910-YL-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Notices]
[Page 28421]
[FR Doc No: 2012-11567]

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

Federal Railroad Administration

[Docket No. FRA-2000-7257: Notice No. 70]

Railroad Safety Advisory Committee; Charter Renewal

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Announcement of Charter Renewal of the Railroad Safety Advisory
Committee (RSAC).

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

SUMMARY: FRA announces the charter renewal of the RSAC, a Federal
Advisory Committee that develops railroad safety regulations through a
consensus process. This charter renewal will take effect on May 17,
2012, and will expire after 2 years.

FOR FURTHER INFORMATION CONTACT: Larry Woolverton, RSAC Designated
Federal Officer/Administrative Officer, FRA, 1200 New Jersey Avenue
SE., Mailstop 25, Washington, DC 20590,<PHONE_NUMBER>; or Robert
Lauby, Acting Associate Administrator for Railroad Safety/Chief Safety
Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC
20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of the
charter renewal for the RSAC. The RSAC was established to provide
advice and recommendations to FRA on railroad safety matters. The RSAC
is composed of 63 voting representatives from 37 member organizations,
representing various rail industry perspectives. In addition, there are
non-voting advisory representatives from the agencies with railroad
safety regulatory responsibility in Canada and Mexico, the National
Transportation Safety Board, the Transportation Safety Administration,
and the Federal Transit Administration. The diversity of the Committee
ensures the requisite range of views and expertise necessary to
discharge its responsibilities. See the RSAC Web site for details on
pending tasks at http://rsac.fra.dot.gov/. Please refer to the notice
published in the Federal Register on March 11, 1996, 61 FR 9740, for
additional information about the RSAC.

    Dated: Issued in Washington, DC, on May 8, 2012.
Robert C. Lauby,
Acting Associate Administrator for Railroad Safety/Chief Safety
Officer.
[FR Doc. 2012-11567 Filed 5-11-12; 8:45 am]
BILLING CODE 4910-06-P