                           SUPPORTING STATEMENT FOR
RENEWABLE FUEL STANDARD (RFS2) VOLUNTARY RIN QUALITY ASSURANCE PROGRAM (FINAL RULE)

A.	JUSTIFICATION

1.	Identification of the Information Collection

	a.	Title:  RFS2 Voluntary RIN Quality Assurance Program, EPA ICR No. 2473.03, OMB Control Number 2060-0688.

	b. 	Short characterization:

	The Renewable Fuel Standard (RFS) program began in 2006 pursuant to the requirements in Clean Air Act (CAA) section 211(o) which were added through the Energy Policy Act of 2005 (EPAct). The statutory requirements for the RFS program were subsequently modified through the Energy Independence and Security Act of 2007 (EISA), resulting in the promulgation of major revisions to the regulatory requirements on March 26, 2010.

	The RFS program requires that specified volumes of renewable fuel be used as transportation fuel, heating oil, and/or jet fuel each year. To accomplish this, the Environmental Protection Agency (EPA) publishes applicable percentage standards annually that apply to the sum of all gasoline and diesel produced or imported. The percentage standards are set so that if every obligated party meets the percentages, then the amount of renewable fuel, cellulosic biofuel, biomass-based diesel, and advanced biofuel used will meet the volumes required on a nationwide basis.

	Obligated parties demonstrate compliance with the standards through the acquisition of unique Renewable Identification Numbers (RINs) assigned by the producer or importer to every batch of renewable fuel produced or imported. Validly generated RINs show that a certain volume of qualifying renewable fuel was produced or imported. The RFS program also includes provisions stipulating the conditions under which RINs are invalid, the liability carried by a party that transfers or uses an invalid RIN, and how invalid RINs must be treated.

	The RIN system within the RFS program contains unique features that make it somewhat challenging for the obligated parties that need RINs for compliance purposes to verify that those RINs have been validly generated. Several cases of fraudulently generated RINs have compelled some obligated parties to limit their business relationships to only those parties that appear most trustworthy. This reaction by the obligated parties made it more difficult for smaller renewable fuel producers to sell their RINs and reduced the overall liquidity of the RIN market. To ensure that RINs are validly generated, individual obligated parties are now conducting their own audits of renewable fuel production facilities, potentially duplicating one another's efforts. These circumstances have created inefficiencies in the RIN market, prompting requests for an additional regulatory mechanism that would reduce the risk of potentially invalid RINs, return liquidity to the RIN market, and reduce the cost of verifying the validity of RINs.

	The EPA finalized the voluntary quality assurance program on July 18, 2014 (79 FR 42078) to provide a more structured way to assure that the RINs entering commerce are valid. The program provides an affirmative defense against violations under certain conditions for the transfer or use of invalid RINs, and specifies both the conditions under which invalid RINs must be replaced with valid RINs, and by whom. The voluntary program enables smaller renewable fuel producers to demonstrate that their RINs are valid, reducing the risk that obligated parties believe is associated with such RINs.

	The voluntary quality assurance program for RINs provides a means for regulated parties to ensure that RINs are properly generated, through audits of production facilities conducted by independent third parties using quality assurance plans (QAPs). To this end, we are promulgating the following:

      ::	Minimum requirements for QAPs, including such things as verification of feedstock type(s), verification that volumes produced are consistent with amount of feedstocks processed, and verification that RINs generated are appropriately categorized and match the volumes produced

      ::	Qualifications for independent third-party auditors

      ::	Requirements for audits of renewable fuel production facilities, including minimum frequency, site visits, review of records, and reporting

      ::	Changes to EMTS that accommodate the quality assurance program

	We believe that the costs associated with this voluntary quality assurance program are warranted to ensure the viability of the renewable fuel and RIN markets. This cost assessment includes the cost of performing audits, to both the fuel producer and the auditor, and the cost to the Agency in implementing this program.

	There are approximately 485 biofuel producers operating more than 600 biofuel production facilities. These numbers are expected to increase as the biofuel market expands. While it is unlikely that all biofuel producers will opt to implement a QAP, that was the assumption for these cost estimates in order to reflect the maximum potential cost of the program.

	No comments were received during the Notice of Proposed Rulemaking (NPRM) comment period on the ICR statement or on the description of impacts and expected costs described in the preamble. This ICR has been updated to reflect changes made to the proposed QAP, particularly a reduction in the required number of facility site visits and related recordkeeping and reporting burden. Most assumptions regarding cost and burden for the final QAP program remain the same as those described for the proposed program.
2. Need For, and Use of, the Collection

      a. Authority for the Collection

	Sections 114 and 208 of the Clean Air Act (CAA), 42 U.S.C. §§ 7414 and 7542, authorize the EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the CAA.

	b. 	Practical Utility/Uses of the Data

	The recordkeeping and reporting requirements of this regulation will allow the EPA to monitor compliance with the RFS program. The quality assurance program helps to ensure that the RIN system operates as originally intended. The primary impacts of the quality assurance program are improved liquidity in the RIN market and improved opportunities for smaller renewable fuel producers to sell their RINs. The data generated by the QAP program will assist obligated parties and smaller renewable fuel producers in complying with the requirements of the RFS program by supporting the validity of RINs.

	The quality assurance program is voluntary. As a result, there are no obligatory costs. There are costs associated with an individual party's participation in the quality assurance program, and in Section 6 we have provided estimates of the costs of participation. These estimates are supported by data provided by several QAP vendors. It is worthwhile to note that, as this is a voluntary program intended to support a current market system, any costs incurred would only be borne if the industry believes that those costs would be less than current costs in the marketplace resulting from efforts to verify, acquire, and trade RINs.

3. Non-duplication, Consultation, and other Collection Criteria

	a. 	Non-duplication

	Efforts have been made to eliminate duplication in this information collection. The QAP may substitute for data previously required in RFS data collection and reporting regulations.

      b. 	Public Notice

	We describe the recordkeeping and reporting requirements for the voluntary QAP program in the final rulemaking and are providing this supporting statement to assist parties potentially considering participation in the program.

	c. 	Consultations

	We met with seven (7) parties who are already developing RIN validation programs for the biofuels industry. We have also met with several industry groups and obligated parties which have been affected by RIN fraud. These parties all provided informal estimates of the costs associated with this type of quality assurance program which were used to inform the cost calculations made for this statement.

	d. 	Effects of Less Frequent Data Collection

	We have designed the reporting schedule to coincide with existing reporting deadlines. Because this is a quality assurance program, more frequent data collection is more likely to ensure the validity of the RINs audited. The program is structured to allow the market to balance the benefits of the program with the costs. Less frequent collection of data would jeopardize the validity of audited RINs and would negatively impact the entire RIN market.

	e. 	General Guidelines

	All Office of Management and Budget (OMB) guidelines are met.

	f. 	Confidentiality

	We inform respondents that they may assert claims of confidential business information (CBI) for the information they submit. We require that actual RINs not be treated as confidential business information under RFS2, as they are necessary identifiers to accompany renewable fuels. In order to ensure transparency in the RIN validation program, as much of the associated data as possible should be made publicly accessible. Any information claimed as confidential will be treated in accordance with 40 CFR Part 2 and established Agency procedures. Information that is received without a claim of confidentiality may be made available to the public without further notice to the submitter under 40 CFR § 2.203.

      g. 	Sensitive Information

	This information collection does not require submission of any sensitive information.

4.	The Respondents and the Information Requested

	a.	Respondents/with NAICS and SIC Codes

	The respondents to this information collection fall into the following general industry categories:  petroleum refineries (324110/2911), ethyl alcohol manufacturers (325193/2869), other basic organic chemical manufacturing (325110/2869), chemical and allied products merchant wholesalers (426990/5169), petroleum bulk stations and terminals (422710/5171), petroleum and petroleum products merchant wholesalers (422720/5172), and other fuel dealers (454319/5989).

	b.	Information Requested

	For those biofuel producers who opt into the QAP, each biofuel production facility must be visited and assessed as part of any audit conducted under the quality assurance program. An auditor must use an approved QAP as the basis for the verification of biofuel produced and RINs generated at a facility. In order to verify production, the auditor must conduct site visits, review documents, and contact entities that do business with the facility. The required components of audits are discussed below.

	Elements of a QAP Audit:

         * Physical Examination of Facility and Operations

      	The goal of the onsite visit is to verify that plant has the technology to produce, store, and blend biofuels at registered levels. The auditor will likely use plant maps and photos as part of this analysis, and should compare and contrast the plant's infrastructure with the third party engineering review reports on file with the EPA. The auditor should note the size and number of storage and blending tanks, and observe the measurement of volume in the tanks. The auditor should determine whether the process rate is consistent with annual production of the facility, and whether the facility has quality process controls in place.

      	We believe that mass and energy balances on the facility are critical components of any audit. Because integrated facilities will likely have energy usage that is not directly related to biofuel production, the auditor should have alternate means of assessing and correlating energy usage to production.

         * Document Review

      	The auditor should ensure that the producer has and is fulfilling the EPA record-keeping requirements at §80.1454(c)(1)(i)(A)-(B) and (ii). We expect the auditor to evaluate reports submitted to the EPA, and that these reports should be year-to-date, as applicable, and from the previous year, for comparison. These include activity reports, RIN transaction reports, RIN generation reports, and renewable fuel producer co-product reports. The third-party engineering review and annual attestation report should also be reviewed. In addition to the above reports, EPA has developed eight forms to help with compliance for the QAP collection.  They are as follows:

      Form Name									Agency Form #

      RFS 1400  -  RFS Renewable Fuel Producers Reporting Fuels				5900-354
      RFS 1500  -  RFS Renewable Fuel producers Reporting Fuels (Finished Fuel Blending)		5900-355
      RFS 1600  -  RFS Renewable Fuel producers Reporting Fuels (Blending Contact)		5900-356
      RFS 2000  -  RFS Independent Third Party Batch Verification				5900-357
      RFS 2100  -  RFS Independent Third Party Batch Verification Aggregate RIN Verification		5900-358
      RFS 2200  -  RFS Independent Third Party On-Site Audit Report				5900-359
      RFS 2300  -  RFS Independent Third Party List of Potentially Invalid RINs			5900-360
      RFS 2400 - Independent Third Party Mass Balance 					5900-361

      	Reports submitted to the EPA as required under § 80.1469 should be cross-checked with other records. For instance, the auditor should have access to certificates of analysis for all batches of feedstocks. The auditor might consider spot-checking recent feedstock receipts (if the producer uses a variety of feedstocks, then the auditor should be provided with receipts for each feedstock). Integrated facilities may not have internal sales receipts for feedstock usage, so an alternative paper trail will likely be required. Similar to the feedstock document review and crosscheck, renewable fuel and co-product delivery documentation should be part of any audit.

         * Review and Reporting

      	We expect the auditor to contact the biofuel producer's customers and suppliers in order to verify sales and purchases. This will likely require ongoing monitoring of the biofuel production facilities by auditor staff or consultants. In addition, auditors are likely to need to track RINs on EMTS. This will ensure that the verified RINs are being reported accurately. Auditors will be responsible for preparing the QAP and submitting it to the EPA.

5.	The Information Collected, Agency Activities, Collection Methodology, and Information Management

	a.	Agency Activities

*          Respond to inquiries on QAP requirements and options
*          Provide copies of the regulations
*          Acknowledge receipt of qualifying QAPs
*          Assist EMTS users with new functions in system related to QAPs
*          Refer violations to enforcement personnel
*          Contact reporting parties if there is a problem with their submission

	b. 	Collection and Methodology and Management

	We will be receiving data in a simplified and secure fashion via the Agency's Central Data Exchange (CDX). Information claimed as CBI will be stored in appropriately controlled areas. Auditors will collect data in a wide variety of ways, as is appropriate to the specific production facility, as indicated in the Information Collected section above. Many of the auditors consulted plan to use electronic, remote sensing, and/or web-based systems to make data collection as efficient as possible.

	c.	Small Entity Flexibility

	This collection will not adversely affect small entities. The final rulemaking describes flexible provisions available to small entities. This program was specifically designed with the small biofuel producer in mind, as they have been the most negatively impacted by the RIN fraud to date.

	d.	Collection Schedule

	We are requiring that an auditor conduct at least two (2) onsite visits per year, or every six (6) months. New production facilities should be audited before startup and, subsequently, according to the standard semi-annual schedule. We expect that each visit could take from one to several days, depending on the size and complexity of the facility, the availability of records, changes since the last audit, etc. For some components of the audit we require real-time, or batch-level monitoring. The QAP is required to provide details of the means for collection and evaluation of the data collected in real-time.

6.	Estimating the Burden and Cost of Collection

      a.	Estimating the Respondent Universe

	We based our estimated number of respondents for this program using the current number of biofuel producers (RIN generators) registered in EMTS plus the total number of registered renewable fuel production facilities. It is unlikely that all biofuel producers will choose to utilize the QAP, in which case the number of respondents would be less than the number assumed here. In order to estimate the maximum cost of this data collection request, we assumed that all parties would opt to use the QAP. It is highly unlikely that all biofuel producers will make this choice, and therefore the costs will likely be lower than those estimated here. Note that the costs are expected to be linear; i.e. there are no economies of scale assumed, based on the number of respondents.

      b.	Estimating the Respondent Burden and Cost

	Respondent costs associated with the RIN quality assurance program include recordkeeping and reporting costs as well as other costs associated with the auditing of renewable fuel production and RIN verification (for example, contract negotiation, site visits, and document review). We expect there will be some start-up/capital costs for auditors who choose to offer the use of remote monitoring, but the Agency is not able to provide any capital cost estimates at this time as doing so could reveal confidential business information. We estimate the total annual hourly burden for respondents to be 263,744 hours.

	Three labor categories are involved:  managerial, technical/professional, and clerical. The estimates use the Bureau of Labor Statistics mean average wages for relevant employee categories (May 2011). The following wages and benefits apply by category:

Wages and Benefits

Managerial 		$55.04 per hour
Technical		$47.81 per hour
Clerical		$18.35 per hour

Doubling for company overhead beyond wages and benefits, and for convenience, rounding up to the dollar, gives the following rates for this ICR:

Total Employer Cost

Managerial		$110 per hour
Technical		$96 per hour
Clerical		$37 per hour

We have estimated the amount of time needed for each labor category, and for each expected step in the QAP development process. These time estimates are shown in Table 1.

c.	Estimating the Agency Burden and Cost

	The EPA must check each QAP submission for completeness. The EPA will be reviewing the qualifications of the QAP providers. Reporting parties must be contacted if there is a problem with their submission. It is anticipated that the QAP will require minimal additional burden and cost on the EPA, relatively to the effort already undertaken for previous RFS reporting requirements.

	This supporting statement considers costs associated with accepting QAP submissions. We anticipate that each QAP will require just four hours of review by one full time GS-13 technical employee at a current pay rate of $44.65 per hour. Doubled to account for overhead and benefits, the hourly agency burden is estimated at $89. These costs are included in Table 1 with the estimated total agency cost at $268,424 per year.

d.	Bottom Line Burden Hours and Costs

	We estimate the following annual totals:

	TOTAL NO. OF RESPONDENTS (RIN generators plus total facility audits):  	 	1313

	TOTAL BURDEN HOURS (RIN generator requirements plus facility audits):    		 263,744

	TOTAL COST TO RESPONDENTS FOR ALL AUDITS:
	$ 22,386,702

e.	Reason for Change in Burden

	The change in burden is due to regulations that allow additional RFS reporting.

f.	Burden Statement

	The annual public reporting and recordkeeping burden for this collection of information is shown in Table 1. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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. The OMB control numbers for the EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, the EPA has established a public docket for this ICR under Docket ID number EPA-HQ-OAR-2005-0161, which is available for online viewing at www.regulations.gov, or in person viewing at the Air Docket in the EPA Docket Center in Washington, DC (EPA/DC). The docket is located in the EPA West Building, 1301 Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30 p.m., Eastern Time, Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.

 	You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number EPA-HQ-OAR-2005-0161. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for the EPA. Please include the EPA Docket ID Number EPA-HQ-OAR-2005-0161 and OMB Control Number 2060-0688 in any correspondence.

 Table 1
RIN Verification, Recordkeeping and Reporting Cost Estimates

                                  Time (hrs)

                                   Category
                                     Mgmt
                                     Prof/
                                     Tech
                                   Clerical
                                     #/yr
                         Other Costs (travel, fees) $
                                   Total Hrs
                                    Total $

RIN Generator:

Site Visit
                                                                              1
                                                                             16
                                                                              4
                                                                              2

                                                                             42
                                                                           3588
Reporting
                                                                              2
                                                                             12
                                                                              4
                                                                              2

                                                                             36
                                                                           3040
Recordkeeping
                                                                              0
                                                                              0
                                                                              2
                                                                              2

                                                                              4
                                                                            148

                                                                             82
                                                                           6776
Auditor:

Contract Initiation
                                                                              4
                                                                              4
                                                                              2
                                                                              1
                                                                            530
                                                                             10
                                                                           1428
Site Visit
                                                                              4
                                                                             16
                                                                              0
                                                                              1
                                                                           1060
                                                                             20
                                                                           3036
Follow-up Visit
                                                                              1
                                                                              6
                                                                              0
                                                                              1
                                                                           1060
                                                                              7
                                                                           1746
Follow-up Verification
                                                                              1
                                                                             16
                                                                             10
                                                                              2

                                                                             54
                                                                           4032
Feedstock suppliers
                                                                              0
                                                                              4
                                                                              0
                                                                              2

                                                                              8
                                                                              0
Process fuel suppliers
                                                                              0
                                                                              4
                                                                              0
                                                                              2

                                                                              8
                                                                              0
Volume/mass balance
                                                                              0
                                                                              4
                                                                              0
                                                                              2

                                                                              8
                                                                              0
Monitoring
                                                                              2
                                                                             50
                                                                              0
                                                                              1

                                                                             52
                                                                           5020
Consultants

                                                                              1
                                                                           1000
                                                                              0
                                                                           1000
Reporting
                                                                              4
                                                                             49
                                                                             32
                                                                              1

                                                                             85
                                                                           6328
Recordkeeping
                                                                              0
                                                                             12
                                                                             25
                                                                              1

                                                                             37
                                                                           2077

                                                                            289
                                                                          24667
EPA:

Implementation

                                                                              4

                                                                              4
                                                                            356

Number of RIN Generators:

                                                                            559
                                                                        45,838
                                                                $    3,787,784

Number of Audits:

                                                                            754
                                                                       217,906
                                                                 $  18,598,918

Industry Total:

                                                                           1313
                                                                       263,744
                                                                 $  22,386,702

EPA:

                                                                            754
                                                                          3,016
                                                              $        268,424

EPA + Industry Total:

                                                                        530,504
                                                                  $ 22,655,126


[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Notices]
[Page 79383-79385]
[DOCID:fr20de10-944]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0528]

Unapproved Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency) is
soliciting comments from stakeholders on strategies to address the
prevalence of animal drug products marketed in the United States
without approval or other legal marketing status. FDA is concerned that
the safety and effectiveness of these actively-marketed products has
not been demonstrated. Therefore, the Agency is requesting comments on
approaches for increasing the number of legally-marketed animal drug
products, as well as on the use of enforcement discretion for some
unapproved animal drug products in certain limited circumstances.

DATES: Submit either electronic or written comments by February 18,
2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>. e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Purpose

    FDA is soliciting comments from all stakeholders, including the
regulated industry, veterinary professionals, and the public on
strategies to address the prevalence of animal drug products marketed
in the United States without approval or other legal marketing status.
The Agency is concerned that the safety and effectiveness of these
marketed products has not been demonstrated. FDA recognizes that the
continued availability of a number of these products is important to
meet the health needs of animals. FDA is requesting comments on
approaches for increasing the number of currently marketed animal drug
products that have legal marketing status. Our focus at this time is
not on revising the current new animal drug approval process. Instead,
we wish to explore additional mechanisms that utilize FDA's existing
regulatory framework as well as novel strategies not currently employed
by the agency to increase the number of approved or otherwise legally
marketed animal drugs. Furthermore, we are requesting comment on the
use of limited enforcement discretion as an element of the overall
strategy.

II. Background

    New animal drugs cannot be legally marketed unless they have been
reviewed and approved, conditionally approved, or index-listed by FDA.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) defines the
term ``drug'' to include articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other
animals, and articles (other than food) intended to affect the
structure or any function of the body of man or other animals (section
201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). The FD&C Act also
defines the term ``new animal drug.'' A ``new animal drug'' includes
any drug intended for use for animals that is not generally recognized
as safe and effective for use under the conditions listed in the drug's
labeling (section 201(v) of the FD&C Act).
    Under the FD&C Act, a new animal drug may not be legally introduced
into interstate commerce unless it is the subject of an approved new
animal drug application (NADA) or abbreviated new animal drug
application (ANADA) under section 512 of the FD&C Act (21 U.S.C. 360b),
a conditional approval (CNADA) under section 571 of the FD&C Act (21
U.S.C. 360ccc), an index listing under section 572 of the FD&C Act (21
U.S.C. 360ccc-1), or an investigational new animal drug exemption
(INAD) under section 512(j) of the FD&C Act (21 U.S.C. 360b(j)). When
this notice refers to an ``unapproved animal drug,'' we mean an animal
drug that does not have a necessary approval, conditional approval,
index listing, or INAD exemption.
    The FD&C Act's new animal drug approval requirements provide
important protection for humans and animals. Animal drugs that are
marketed without required FDA review and approval may not meet
requirements and standards for, among other things, safety and
effectiveness. The FDA drug approval process ensures, through an
evaluation of scientific evidence, that animal drugs are safe and
effective. The approval process also provides a review of product-
specific information that is critical to ensuring the safety and
effectiveness of the finished animal drug product. For instance, the
sponsor of an NADA must demonstrate that the manufacturing processes
can reliably produce drug products of expected identity, strength,
quality, and purity. Furthermore, FDA's review of the applicant's
labeling assures that veterinarians, animal owners and other consumers
have the information necessary to understand a drug product's risks. In
addition, firms marketing approved animal drug products must report
adverse events associated with their product's use, which helps FDA
continuously assess the risks associated with a particular product.
Although the conditional approval and indexing requirements differ in
some ways from the animal drug approval process, they all provide for a
science-based review to assure the drug will be safe for its intended
use. FDA employs these standards in the new animal drug approval
process to protect both human and animal health.
    For many years, FDA has been aware that a wide variety of animal
drug products are being marketed that meet the definition of ``drug''
and ``new animal drug'' as defined in the FD&C Act, but are not
approved, conditionally approved, or indexed. Many of these unapproved
animal drugs were, and some continue to be, the standard of care in
treating animals, and some are essential to protecting animal health
and ensuring an adequate food supply.
    In general, the types of unapproved animal drugs being marketed
include, but are not limited to, injectable vitamins, various topical
solutions, shampoos, and liniments, electrolyte and glucose solutions,
and antidotes. In addition, there are a variety of anti-infective and
other animal drug products marketed for use in a variety of animal
species. The Agency determined, based on available information, that
some of these animal drug products or categories of products did not
raise safety concerns. With respect to those products, the Agency
historically exercised its enforcement discretion, even though such
products lacked the required FDA marketing approval. This approach has
been important for setting enforcement priorities and for making
decisions as to whether to take action against an illegally marketed
unapproved drug or class of drugs under particular circumstances.
    Some of these unapproved drugs which did not raise safety concerns
have been marketed under an FDA letter of ``no objection,'' issued in
response to a firm's request, stating that FDA did not at the time
object to the marketing of a particular unapproved new animal

drug. In addition, some unapproved drugs have been marketed under the
auspices of Compliance Policy Guides issued by FDA to let its staff,
the public, and industry know the conditions under which FDA would
consider enforcement action with respect to these unapproved drugs.
This practice of proactively announcing the Agency's intent to exercise
enforcement discretion with respect to particular types of unapproved
drugs under specified conditions has been used in certain circumstances
because of the relatively limited number of approved animal drugs
available to meet the animal health needs of a diverse number of animal
species.
    FDA recognizes that it will be necessary to continue to exercise
enforcement discretion in limited circumstances for certain essential
unapproved animal drug products or categories of products as the Agency
works to develop new ways to increase the availability of products that
are approved or otherwise legally marketed. However, it is the Agency's
general expectation that new animal drugs must be approved or otherwise
legally marketed as required by the FD&C Act. Therefore, any exercise
of the Agency's enforcement discretion with respect to unapproved
animal drugs should be limited to the greatest extent possible. To that
end, the Agency is seeking comment on strategies for increasing the
number of animal drug products that are legally marketed, and thus
decreasing the number of currently marketed products that lack approval
or other legal marketing status. Such strategies may include
alternative pathways to achieve legal marketing status that assure
animal drug products meet safety and effectiveness standards, including
human food safety standards. However, even after alternative pathways
to legal marketing are established, some drugs may not be well-suited
to such alternatives and may be required to go through the new animal
drug approval process, especially in cases where there are safety or
effectiveness concerns. For example, certain drug products intended for
use in food-producing animals may only be able to achieve legal
marketing status through the traditional new animal drug approval
process because of concerns about drug residues appearing in edible
tissues.

III. Agency Request for Comments

    FDA is soliciting public comment on potential actions the Agency
can take to help achieve the goal of obtaining legal marketing status,
as appropriate, for unapproved animal drugs that are currently being
marketed in the United States. We are interested in comments on
strategies that utilize FDA's existing regulatory framework for
addressing this issue as well as comments on novel strategies not
currently employed by the Agency. In conjunction with pursuing this
goal, the Agency recognizes the need for maintaining the availability
of essential animal drugs for pet owners, veterinarians, and animal
producers.
    FDA is also specifically requesting comments and information on the
questions and subjects below. This list is not all-inclusive, however,
and is not intended to limit the range of options available for public
comment. The Agency asks that comments be as detailed as possible, with
explanations and information to assist FDA in evaluating whether the
approaches will help accomplish the goal of increasing the number of
currently marketed animal drug products that have approval or other
legal marketing status. FDA's intent is that of inquiry and not for
anyone to read this list as any indication of the Agency's position on
a particular approach or a determination that the Agency has the
resources to implement such an approach.

A. Increasing the Availability of Legally Marketed Animal Drug Products

    In general, the types of unapproved animal drugs being marketed
include, but are not limited to: Injectable vitamins; various topical
solutions, shampoos, and liniments; electrolyte and glucose solutions;
and antidotes. In addition, there are a variety of anti-infective and
other animal drug products marketed for use in a variety of animal
species. Given the broad array of animal drug products that are
important for meeting the health needs of a diverse number of animal
species, FDA is interested in exploring alternative approaches (i.e.,
alternatives to the existing new animal drug approval process) by which
those products could be legally marketed. Some examples of alternative
approaches are discussed in sections III.A.1 and III.A.2 of this
document.
1. Monographs
    Certain over-the-counter (OTC) drugs for humans are marketed under
monographs that establish the conditions under which these drugs are
generally recognized as safe and effective and not misbranded. The
monographs specify active ingredients, dosage forms, product strengths,
indications for use, labeling, and other conditions. Human OTC drug
products that comply with all of a monograph's conditions and the
provisions in 21 CFR part 330 may be manufactured and distributed
without applications or any other premarket review. Monographs are
developed after review of available information about safety and
effectiveness, including published and unpublished data and information
submitted to the Agency, and must be supported by adequate and well-
controlled studies.
    Does published literature of sufficient quality exist for some
currently marketed unapproved animal drugs such that monographs might
be a feasible approach? For which drugs might this be feasible? What
are the attributes that make the published literature suitable for this
purpose? What criteria should be used to determine whether an animal
drug is potentially suitable for a monograph to ensure that quality,
safety and effectiveness would not be compromised in the absence of
premarket review?
2. Use of Publicly Available Information
    In some cases, human prescription drugs have been approved and
marketed after FDA reviewed the existing literature and data regarding
a particular drug or class of drugs. Examples of drugs for which FDA
has used this approach include the following:
     Prussian Blue (see ``Guidance for Industry on Prussian
Blue for Treatment of Internal Contamination With Thallium or
Radioactive Cesium; Availability'' (68 FR 5645, February 4, 2003)) and
     Pancreatic Enzymes (see ``Exocrine Pancreatic
Insufficiency Drug Products'' (69 FR 23410, April 28, 2004), ``Exocrine
Pancreatic Insufficiency Drug Products for Over-the-Counter Human Use''
(56 FR 32282, July 15, 1991), and ``Guidance for Industry: Exocrine
Pancreatic Insufficiency Drug Products--Submitting NDAs,'' issued in
April 2006 and available online at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm071651.pdf).
    For each of these drugs, FDA reviewed the publicly available
information and published in the Federal Register a discussion
regarding the drug's safety and effectiveness, and any conclusions
reached by the Agency based on that review. Firms then submitted drug
applications referencing the public information and/or the Federal
Register notice to address certain information requirements needed for
an application.
    Does published literature of sufficient quality exist for some
animal drugs that could be used to support safety and effectiveness
evaluations for these

currently unapproved marketed drugs? For which drugs might this be
feasible? What attributes make published literature of sufficient
quality to contribute to such an evaluation?

B. Limiting the Use of Enforcement Discretion

    As stated previously, the Agency acknowledges that the practice of
exercising enforcement discretion in certain circumstances is necessary
to ensure the availability of some essential animal drug products. This
practice of exercising enforcement discretion (i.e., a decision on the
part of the Agency to not take enforcement action in certain
circumstances) is not only important for managing limited Agency
resources related to compliance activities but is also important for
assuring that certain animal drug products remain available for
addressing the health needs of animals. However, FDA's goal is to
limit, to the extent possible, its use of enforcement discretion for
unapproved animal drugs.
    What factors should the Agency consider when determining which
unapproved animal drug products or categories of products should be the
subject of enforcement discretion?

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31889 Filed 12-17-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Notices]
[Pages 58495-58496]
[FR Doc No: 2022-20871]

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

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: RP22-1224-000.
    Applicants: MP Gulf of Mexico, LLC, Deepwater Abandonment
Alternatives, Inc.
    Description: Joint Petition for Temporary and Limited Waivers of
Capacity Release Regulations, et al. of MP Gulf of Mexico, LLC et al.
under RP22-1224.
    Filed Date: 9/19/22.
    Accession Number: 20220919-5267.
    Comment Date: 5 p.m. ET 9/26/22.

    Docket Numbers: RP22-1225-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Sec.  4(d) Rate Filing: Off-System Capacity Updates to
be effective 10/20/2022.
    Filed Date: 9/20/22.
    Accession Number: 20220920-5109.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: RP22-1226-000.
    Applicants: Flywheel Energy Production II, LLC, XTO Energy Inc.
    Description: Joint Petition for Temporary Waivers of Capacity
Release Regulations, et al. of Flywheel Energy Production II, LLC et
al. under RP22-1226.
    Filed Date: 9/20/22.
    Accession Number: 20220920-5110.
    Comment Date: 5 p.m. ET 9/27/22.

    Docket Numbers: RP22-1227-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: KaMin Negotiated Rate to be
effective 10/1/2022.

    Filed Date: 9/21/22.
    Accession Number: 20220921-5011.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: RP22-1228-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Removal of Expiring NextEra
Agreement to be effective 11/1/2022.
    Filed Date: 9/21/22.
    Accession Number: 20220921-5014.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: RP22-1229-000.
    Applicants: Honeoye Storage Corporation.
    Description: Compliance filing: HSC 2022 Rate Compliance Filing to
be effective N/A.
    Filed Date: 9/21/22.
    Accession Number: 20220921-5018.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: RP22-1230-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2022-09-21 Negotiated Rate
Agreement Termination to be effective 9/16/2022.
    Filed Date: 9/21/22.
    Accession Number: 20220921-5028.
    Comment Date: 5 p.m. ET 10/3/22.

    Docket Numbers: RP22-1231-000.
    Applicants: Tallgrass Interstate Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: TIGT 2022-09-21 Non-Conforming
Agreement Amendment to be effective 9/21/2022.
    Filed Date: 9/21/22.
    Accession Number: 20220921-5032.
    Comment Date: 5 p.m. ET 10/3/22.

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

    Dated: September 21, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-20871 Filed 9-26-22; 8:45 am]
BILLING CODE 6717-01-P


business information; Fraud Reporting and recordkeeping requirements;
Securities; Swaps.

17 CFR Part 249

    Administrative practice and procedure; Brokers; Reporting and
recordkeeping requirements; Securities.

Text of the Amendments

    For the reasons set out in the preamble, title 17, chapter II of
the Code of Federal Regulations is amended to read as follows:

PART 240--GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF
1934

0
1. The authority citation for part 240 continues to read in part as
follows:

    Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3,
77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f,
78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78o, 78o-4,
78o-10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78x, 78dd, 78ll, 78mm,
80a-20, 80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, and 7201 et
seq., and 8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 18 U.S.C.
1350; Pub. L. 111-203, 939A, 124 Stat. 1376 (2010); and Pub. L. 112-
106, sec. 503 and 602, 126 Stat. 326 (2012), unless otherwise noted.
* * * * *
    Section 240.21F is also issued under Pub. L. 111-203, 922(a),
124 Stat. 1841 (2010).
* * * * *

0
2. Section 240.21F-2 is revised to read as follows:

Sec.  240.21F-2  Whistleblower status, award eligibility,
confidentiality, and retaliation protections.

    (a) Whistleblower status. (1) You are a whistleblower for purposes
of Section 21F of the Exchange Act (15 U.S.C. 78u-6) as of the time
that, alone or jointly with others, you provide the Commission with
information in writing that relates to a possible violation of the
federal securities laws (including any law, rule, or regulation subject
to the jurisdiction of the Commission) that has occurred, is ongoing,
or is about to occur.
    (2) A whistleblower must be an individual. A company or other
entity is not eligible to be a whistleblower.
    (b) Award eligibility. To be eligible for an award under Section
21F(b) of the Exchange Act (15 U.S.C. 78u-6(b)) based on any
information you provide that relates to a possible violation of the
federal securities laws, you must comply with the procedures and the
conditions described in Sec. Sec.  240.21F-4, 240.21F-8, and 240.21F-9.
You should carefully review those rules before you submit any
information that you may later wish to rely upon to claim an award.
    (c) Confidentiality protections. To qualify for the confidentiality
protections afforded by Section 21F(h)(2) of the Exchange Act (15
U.S.C. 78u-6(h)(2)) based on any information you provide that relates
to a possible violation of the federal securities laws, you must comply
with the procedures and the conditions described in Rule 21F-9(a)
(Sec.  240.21F-9(a)).
    (d) Retaliation protections. (1) To qualify for the retaliation
protections afforded by Section 21F(h)(1) of the Exchange Act (15
U.S.C. 78u-6(h)(1)), you must satisfy all of the following criteria:
    (i) You must qualify as a whistleblower under paragraph (a) of this
section before experiencing the retaliation for which you seek redress;
    (ii) You must reasonably believe that the information you provide
to the Commission under paragraph (a) of this section relates to a
possible violation of the federal securities laws; and
    (iii) You must perform a lawful act that meets the following two
criteria:
    (A) First, the lawful act must be performed in connection with any
of the activities described in Section 21F(h)(1)(A)(i) through (iii) of
the Exchange Act (15 U.S.C. 78u-6(h)(1)(A)(i) through (iii)); and
    (B) Second, the lawful act must relate to the subject matter of
your submission to the Commission under paragraph (a) of this section.

    (2) To receive retaliation protection for a lawful act described in
paragraph (d)(1)(iii) of this section, you do not need to qualify as a
whistleblower under paragraph (a) of this section before performing the
lawful act, but you must qualify as a whistleblower under paragraph (a)
of this section before experiencing retaliation for the lawful act.
    (3) To qualify for retaliation protection, you do not need to
satisfy the procedures and conditions for award eligibility in
Sec. Sec.  240.21F-4, 240.21F-8, and 240.21F-9.
    (4) Section 21F(h)(1) of the Exchange Act (15 U.S.C. 78u-6(h)(1)),
including any rules promulgated thereunder, shall be enforceable in an
action or proceeding brought by the Commission.

0
3. Amend Sec.  240.21F-3 by revising paragraphs (b)(1) and (3) to read
as follows:

Sec.  240.21F-3  Payment of awards.

* * * * *
    (b) * * *
    (1) A related action is a judicial or administrative action that is
brought by one of the governmental entities listed in paragraphs
(b)(1)(i) through (iii) of this section or a self-regulatory
organization as specified in paragraph (b)(1)(iv) of this section
(collectively ``governmental/SRO authority''), that yields monetary
sanctions, and that is based upon information that either the
whistleblower provided directly to a governmental/SRO entity or the
Commission itself passed along to the governmental/SRO entity pursuant
to the Commission's procedures for sharing information, and which is
the same original information that the whistleblower voluntarily
provided to the Commission and that led the Commission to obtain
monetary sanctions totaling more than $1,000,000.
    (i) The Attorney General of the United States;
    (ii) An appropriate regulatory authority (as defined in Sec.
240.21F-4); or
    (iii) A state Attorney General in a criminal case; or
    (iv) A self-regulatory organization (as defined in Sec.  240.21F-
4).
* * * * *
    (3) The following provision shall apply where a claimant's
application for a potential related action may also involve a potential
recovery from another whistleblower award program for that same action.
    (i) Notwithstanding paragraph (b)(1) of this section, if a judicial
or administrative action is subject to a separate monetary award
program established by the Federal Government, a state government, or a
self-regulatory organization, the Commission will deem the action a
related action only if the Commission finds (based on the facts and
circumstances of the action) that its whistleblower program has the
more direct or relevant connection to the action.
    (ii) In determining whether a potential related action has a more
direct or relevant connection to the Commission's whistleblower program
than another award program, the Commission will consider the nature,
scope, and impact of the misconduct charged in the potential related
action, and its relationship to the Federal securities laws. This
inquiry may include consideration of, among other things:
    (A) The relative extent to which the misconduct charged in the
potential related action implicates the public policy interests
underlying the Federal securities laws (such as investor protection)
rather than other law-enforcement or regulatory interests (such as tax
collection or fraud against the Federal Government);
    (B) The degree to which the monetary sanctions imposed in the
potential related action are attributable to conduct that also
underlies the Federal securities law violations that were the subject
of the Commission's enforcement action; and
    (C) Whether the potential related action involves state-law claims
and the extent to which the state may have a whistleblower award
program that potentially applies to that type of law-enforcement
action.
    (iii) If the Commission determines to deem the action a related
action, the Commission will not make an award to you for the related
action if you have already been granted an award by the governmental/
SRO entity responsible for administering the other whistleblower award
program. Further, if you were denied an award by the other award
program, you will not be permitted to readjudicate any issues before
the Commission that the governmental/SRO entity responsible for
administering the other whistleblower award program resolved against
you as part of the award denial. Additionally, if the Commission makes
an award before an award determination is finalized by the
governmental/SRO entity responsible for administering the other award
program, the Commission shall condition its award on the meritorious
whistleblower making a prompt, irrevocable waiver of any claim to an
award from the other award program.

0
4. Amend Sec.  240.21F-4 by:
0
 a. Revising paragraph (c)(2);
0
b. Adding paragraph (d)(3); and
0
c. Revising paragraph (e).
    The revisions and addition read as follows:

Sec.  240.21F-4  Other definitions.

* * * * *
    (c) * * *
* * * * *
    (2) You gave the Commission original information about conduct that
was already under examination or investigation by the Commission, the
Congress, any other authority of the federal government, a state
Attorney General or securities regulatory authority, any self-
regulatory organization, or the PCAOB (except in cases where you were
an original source of this information as defined in paragraph (b)(5)
of this section), and your submission significantly contributed to the
success of the action.
* * * * *
    (d) * * *
* * * * *
    (3) For purposes of making an award under Sec. Sec.  240.21F-10 and
240.21F-11, the following will be deemed to be an administrative action
and any money required to be paid thereunder will be deemed a monetary
sanction under Sec.  240.21F-4(e):
    (i) A non-prosecution agreement or deferred prosecution agreement
entered into by the U.S. Department of Justice; or
    (ii) A similar settlement agreement entered into by the Commission
outside of the context of a judicial or administrative proceeding to
address violations of the securities laws.
    (e) Monetary sanctions means:
    (1) An order to pay money that results from a Commission action or
related action and which is either:
    (i) Expressly designated as a penalty, disgorgement, or interest;
or
    (ii) Otherwise ordered as relief for the violations that are the
subject of the covered action or related action; or
    (2) Any money deposited into a disgorgement fund or other fund
pursuant to section 308(b) of the Sarbanes-Oxley Act of 2002 (15 U.S.C.
7246(b)), as a result of such action or any settlement of such action.
* * * * *

0
 5. Amend Sec.  240.21F-6 by:
0
a. Revising the first sentence of the introductory text; and
0
b. Adding paragraph (c).
    The revision and addition read as follows:

Sec.  240.21F-6  Criteria for determining amount of award.

    In exercising its discretion to determine the appropriate award,
the Commission may consider the following factors (and only the
following factors) in relation to the facts and circumstances of each
case in setting the dollar or percentage amount of the award. * * *
* * * * *
    (c) Additional considerations in connection with certain awards of
$5 million or less. (1) This subpart applies when the Commission is
considering any meritorious award application where:
    (i) The statutory maximum award of 30 percent of the monetary
sanctions collected in any covered and related action(s), in the
aggregate, is $5 million or less, and the Commission determines that it
does not reasonably anticipate that future collections would cause the
statutory maximum award to be paid to any whistleblower to exceed $5
million in the aggregate;
    (ii) None of the negative award factors specified in paragraphs
Sec. Sec.  240.21F-6(b)(1) or 240.21F-6(b)(3) were found present with
respect to the claimant's award application, and the award claim does
not trigger Sec.  240.21F-16 (concerning awards to whistleblowers who
engage in culpable conduct);
    (iii) The claimant did not engage in unreasonable reporting delay
under Sec.  240.21F-(6)(b)(2) (although the Commission, in its sole
discretion, may in certain limited circumstances determine to waive
this criterion if the claimant can demonstrate that doing so based on
the facts and circumstances of the matter is consistent with the public
interest, the promotion of investor protection, and the objectives of
the whistleblower program); and
    (iv) The Commission does not otherwise determine in its sole
discretion that application of the enhancement afforded by this subpart
would be inappropriate because either:
    (A) The whistleblower's assistance in the covered action or related
action (as assessed under Sec.  240.21F-6(a) of this section) was,
under the relevant facts and circumstances, limited; or
    (B) Providing the enhancement would be inconsistent with the public
interest, the promotion of investor protection, or the objectives of
the whistleblower program.
    (2) If the Commission determines that the criteria in Sec.
240.21F-6(c)(1) are satisfied, the resulting payout to a claimant for
the original information that the claimant provided that led to one or
more successful covered or related action(s), collectively, will be the
maximum allowed under the statute.
    (3) Notwithstanding Sec.  240.21F-6(c)(2), if two or more claimants
qualify for an award in connection with any covered action or related
action and at least one of those claimant's award applications
qualifies under Sec.  240.21F-6(c)(1), the aggregate amount awarded to
all meritorious claimants will be the statutory maximum. In allocating
that amount among the meritorious claimants, the Commission will
consider whether an individual claimant's award application satisfies
Sec. Sec.  240.21F-6(c)(1)(ii) and 240.21F-6(c)(1)(iii).

0
6. Amend Sec.  Section 240.21F-7 by revising the introductory text of
paragraph (a) to read as follows:

Sec.  240.21F-7  Confidentiality of submissions

    (a) Pursuant to Section 21F(h)(2) of the Exchange Act (15 U.S.C.
78u-6(h)(2)) and Sec.  240.21F-2(c), the Commission will not disclose
information that could reasonably be expected to reveal the identity of
a whistleblower provided that the whistleblower has submitted
information utilizing the processes specified in Sec.  240.21F-9(a),
except that the Commission may disclose such information in the
following circumstances:
* * * * *

0
7. Amend Sec.  240.21F-8 by:
0
a. Revising the section heading;
0
b. Revising paragraph (c)(7); and
0
c. Adding paragraphs (d) and (e).
    The revisions and additions read as follows:

Sec.  240.21F-8  Eligibility and forms.

* * * * *
    (c) * * *
    (7) The Commission or a court of competent jurisdiction finds that,
in your whistleblower submission, your other dealings with the
Commission (including your dealings beyond the whistleblower program
and covered action), or your dealings with another governmental/SRO
entity (as specified in Sec.  240.21F-3(b)(1)) in connection with a
related action, you knowingly and willfully made any materially false,
fictitious, or fraudulent statement or representation, or used any
false writing or document knowing that it contains any materially
false, fictitious, or fraudulent statement or entry with intent to
mislead or otherwise hinder the Commission or another governmental/SRO
entity, provided that this provision should not apply if the
Commission, in its discretion, finds it consistent with the public
interest, the promotion of investor protection, and the objectives of
the whistleblower program.
    (d) The Commission may modify or revise Form TCR and Form WB-APP as
provided below.
    (1) The Commission will periodically designate on the Commission's
web page a Form TCR (Tip, Complaint, or Referral) that individuals
seeking to be eligible for an award through the process identified in
Sec.  240.21F-9(a)(2) shall use.
    (2) The Commission will also periodically designate on the
Commission's web page a Form WB-APP for use by individuals seeking to
apply for an award in connection with a Commission-covered judicial or
administrative action (15 U.S.C. 21F(a)(1)), or a related action (Sec.
240.21F-3(b)(1)).
    (e) The Commission shall have the authority to impose a permanent
bar on a claimant as provided below.
    (1) Grounds for a permanent bar. Submissions or applications that
are frivolous or fraudulent, or that would otherwise hinder the
effective and efficient operation of the Whistleblower Program may
result in the Commission issuing a permanent bar as part of a final
order in the course of considering a whistleblower award application
from you. If such a bar is issued, the Office of the Whistleblower will
not accept or act on any other applications from you. A permanent bar
may be issued in the following circumstances:
    (i) If you make three or more award applications for Commission
actions that the Commission finds to be frivolous or lacking a
colorable connection between the tip (or tips) and the Commission
actions for which you are seeking awards; or
    (ii) If the Commission finds that you have violated paragraph
(c)(7) of this section.
    (2) General procedures for issuance of a permanent bar. The
Commission will consider whether to issue a permanent bar in connection
with an award application from you. In general, the Preliminary
Determination or Preliminary Summary Disposition must state that a bar
is being recommended, and you will then have an opportunity to respond
in writing in accordance with the award processing procedures specified
in Sec. Sec.  240.21F-10(e)(2) and 240.21F-18(b)(3). If the basis for a
bar arises or is discovered after the issuance of a Preliminary
Determination or Preliminary Summary Disposition, the Office of the
Whistleblower shall notify you and afford you an opportunity to submit
a response before the

Commission determines whether to issue a bar.
    (3) Notice and opportunity to withdraw frivolous applications. (i)
Except as provided in paragraph (e)(3)(ii) of this section, before any
Preliminary Determination or Preliminary Summary Disposition is issued
that may recommend a bar, the Office of the Whistleblower shall advise
you of any assessment by that Office that your award application is
frivolous (``frivolous application'') or based on a tip that lacks a
colorable connection to the action for which you have sought an award
(``noncolorable application''). If you withdraw your award application
within 30 days of the notification from the Office of the
Whistleblower, it will not be considered by the Commission in
determining whether to exercise its authority under this paragraph (e).
    (ii) The notification and opportunity to withdraw provided for by
paragraph (e)(3)(i) are limited to the first three applications
submitted by you that are reviewed by the Office of the Whistleblower
and preliminarily deemed by that Office to be either a frivolous
application or a noncolorable application. After these first three
award applications, you will not be provided notice or an opportunity
to withdraw any other frivolous or noncolorable applications.
    (iii) For purposes of determining whether a bar should be imposed
under section (e) of this rule, you will not be permitted to withdraw
your application:
    (A) After the 30-day period to withdraw has run following notice
from the Office of the Whistleblower with respect to the initial three
applications assessed by that Office to be frivolous or lacking a
colorable connection to the action; or
    (B) After a Preliminary Determination or Preliminary Summary
Disposition has issued in connection with any other such application.
    (4) Award applications pending before the effective date of
paragraph (e). (i) Paragraph (e) of this section shall apply to all
award applications pending as of the effective date of paragraph (e) of
this section. But with respect to any such pending award applications,
the Office of the Whistleblower shall advise you, before any
Preliminary Determination or Preliminary Summary Disposition is issued
that may recommend a bar, of any assessment by that Office that the
conditions for issuing a bar are satisfied because either:
    (A) You submitted an award application prior to the effective date
of this section (e) and that application is frivolous or lacking a
colorable connection between the tip and the action for which you have
sought an award; or
    (B) You made a materially false, fictitious, or fraudulent
statement or representation or used a false writing or document in
violation of paragraph (c)(7) of this section prior to the effective
date of this section (e).
    (ii) If, within 30 days of the Office of the Whistleblower
providing the foregoing notification, you withdraw the relevant award
application(s), the withdrawn award application(s) will not be
considered by the Commission in determining whether to exercise its
authority under paragraph (e). Further, the procedures specified in
paragraph (e)(3)(i) through (iii) of this section shall apply to any
award application that is pending as of the effective date of this rule
that is determined to be a frivolous or noncolorable application.

0
8. Amend Sec.  240.21F-9 by:
0
a. Revising paragraphs (a) and (b); and
0
b. Removing the parenthetical phrase ``(referenced in Sec.  249.1800 of
this chapter)'' wherever it appears in paragraphs (c) introductory
text, (c)(2), (c)(3), (c)(4), and (d); and
0
c. Adding paragraph (e).
    The revisions read as follows:

Sec.  240.21F-9   Procedures for submitting original information.

    (a) To submit information in a manner that satisfies Sec.  240.21F-
2(b) and Sec.  240.21F-2(c) of this chapter you must submit your
information to the Commission by any of these methods:
    (1) Online, through the Commission's website located at
www.sec.gov, using the Commission's electronic TCR portal (Tip,
Complaint, or Referral);
    (2) Mailing or faxing a Form TCR to the SEC Office of the
Whistleblower at the mailing address or fax number designated on the
SEC's web page for making such submissions; or
    (3) By any other such method that the Commission may expressly
designate on its website as a mechanism that satisfies Sec. Sec.
240.21F-2(b) and 240.21F-2(c) of this chapter. For a 30-day period
following the Commission's designation of any new forms by placing them
on the Commission's website, the Commission shall also continue to
accept submissions made using the prior version of the forms.
    (b) Further, to be eligible for an award, you must declare under
penalty of perjury at the time you submit your information pursuant to
paragraph (a)(1), (a)(2), or (a)(3) of this section that your
information is true and correct to the best of your knowledge and
belief.
* * * * *
    (e) You must follow the procedures specified in paragraphs (a) and
(b) of this section within 30 days of when you first provide the
Commission with original information that you rely upon as a basis for
claiming an award. If you fail to do so, then you will be deemed
ineligible for an award in connection with that information (even if
you later resubmit that information in accordance with paragraphs (a)
and (b) of this section). Notwithstanding the foregoing, the Commission
shall waive your noncompliance with paragraphs (a) and (b) of this
section if:
    (1) You demonstrate to the satisfaction of the Commission that you
complied with the requirements of paragraphs (a) and (b) of this
section within 30 days of first obtaining actual or constructive notice
about those requirements (or 30 days from the date you retain counsel
to represent you in connection with your submission of original
information, whichever occurs first); and
    (2) The Commission can readily develop an administrative record
that unambiguously demonstrates that you would otherwise qualify for an
award.

0
9. Amend Sec.  240.21F-10 by revising paragraphs (b), (c), (d), and (e)
to read as follows:

Sec.  240.21F-10  Procedures for making a claim for a whistleblower
award in SEC actions that result in monetary sanctions in excess of
$1,000,000.

* * * * *
    (b) To file a claim for a whistleblower award, you must file Form
WB-APP (as specified in Sec.  240.21F-8(d)(2). You must sign this form
as the claimant and submit it to the Office of the Whistleblower by
mail, email (as a PDF attachment), or fax (or any other manner that the
Office permits).
    (1) All claim forms, including any attachments, must be received by
the Office of the Whistleblower within ninety (90) calendar days of the
date of the Notice of Covered Action in order to be considered for an
award.
    (2) Notwithstanding paragraphs (a) and (b)(1) of this section, the
time period to file an application for an award based on a Commission
settlement agreement covered by Sec.  240.21F-4(d) of this chapter
shall be governed exclusively by Sec.  240.21F-11(b)(1) of this chapter
if the settlement agreement was entered into after July 21, 2010 but
before the effective date of this section as amended in 2020.
    (c) If you provided your original information to the Commission
anonymously, you must disclose your identity on the Form WB-APP, and
your identity must be verified in a form and manner that is acceptable
to the Office

of the Whistleblower prior to the payment of any award.
    (d) Once the time for filing any appeals of the Commission's
judicial or administrative action has expired, or where an appeal has
been filed, after all appeals in the action have been concluded, one or
more staff members designated by the Director of the Division of
Enforcement (``Claims Review Staff'') will evaluate all timely
whistleblower award claims submitted on Form WB-APP in accordance with
the criteria set forth in these rules. In connection with this process,
the Office of the Whistleblower may require that you provide additional
information relating to your eligibility for an award or satisfaction
of any of the conditions for an award, as set forth in Sec.  240.21F-
8(b) of this chapter. Following a determination by the Claims Review
Staff (and an opportunity for the Commission to review that
determination), the Office of the Whistleblower will send you a
Preliminary Determination setting forth a preliminary assessment as to
whether the claim should be allowed or denied and, if allowed, setting
forth the proposed award dollar and percentage amount, and the grounds
therefore.
    (e) You may contest the Preliminary Determination made by the
Claims Review Staff by submitting a written response to the Office of
the Whistleblower setting forth the grounds for your objection to
either the denial of an award or the proposed amount of an award. The
response must be in the form and manner that the Office of the
Whistleblower shall require. You may also include documentation or
other evidentiary support for the grounds advanced in your response. In
applying the award factors specified in Sec.  240.21F-6 of this chapter
and determining the award dollar and percentage amounts set forth in
the Preliminary Determination, the award factors may be considered by
the SEC staff and the Commission in dollar terms, percentage terms or
some combination thereof. Should you choose to contest a Preliminary
Determination, you may set forth the reasons for your objection to the
proposed amount of an award, including the grounds therefore, in dollar
terms, percentage terms or some combination thereof.
    (1) Before determining whether to contest a Preliminary
Determination, you may:
    (i) Within thirty (30) days of the date of the Preliminary
Determination, request that the Office of the Whistleblower make
available for your review the materials from among those set forth in
Sec.  240.21F-12(a) of this chapter that formed the basis of the Claims
Review Staff's Preliminary Determination.
    (ii) Within thirty (30) calendar days of the date of the
Preliminary Determination, request a meeting with the Office of the
Whistleblower; however, such meetings are not required and the office
may in its sole discretion decline the request.
    (2) If you decide to contest the Preliminary Determination, you
must submit your written response and supporting materials within sixty
(60) calendar days of the date of the Preliminary Determination, or if
a request to review materials is made pursuant to paragraph (e)(1) of
this section, then within sixty (60) calendar days of the Office of the
Whistleblower making those materials available for your review.
* * * * *

0
10. Amend Sec.  240.21F-11 by revising paragraphs (b), (c), (d), and
(e) to read as follows:

Sec.  240.21F-11  Procedures for determining awards based upon a
related action.

* * * * *
    (b) You must also use Form WB-APP (as specified in Sec.  240.21F-
8(d)(2)) to submit a claim for an award in a potential related action.
You must sign this form as the claimant and submit it to the Office of
the Whistleblower by mail, email (as a PDF attachment), or fax (or any
other manner that the Office permits) as follows:
    (1) If a final order imposing monetary sanctions has been entered
in a potential related action at the time you submit your claim for an
award in connection with a Commission action, you must submit your
claim for an award in that related action on the same Form WB-APP that
you use for the Commission action. For purposes of this paragraph and
paragraph (b)(2) of this section, a final order imposing monetary
sanctions is entered on the date of a court or administrative order
imposing the monetary sanctions; however, with respect to any agreement
covered by Sec.  240.21F-4(d) of this chapter (such as a deferred
prosecution agreement or a nonprosecution agreement entered by the
Department of Justice), the Commission will deem the date of the entry
of the final order to be the later of either:
    (i) The effective date of this section as amended in 2020; or
    (ii) The date of the earliest public availability of the instrument
reflecting the arrangement if evidenced by a press release or similar
dated publication notice (or otherwise, the date of the last signature
necessary for the agreement).
    (2) If a final order imposing monetary sanctions in a potential
related action has not been entered at the time you submit your claim
for an award in connection with a Commission action, you must submit
your claim on Form WB-APP within ninety (90) days of the issuance of a
final order imposing sanctions in the potential related action.
    (c) The Office of the Whistleblower may request additional
information from you in connection with your claim for an award in a
related action to demonstrate that you directly (or through the
Commission) voluntarily provided the governmental/SRO entity (as
specified in Sec.  240.21F-3(b)(1) of this chapter) the same original
information that led to the Commission's successful covered action, and
that this information led to the successful enforcement of the related
action. Further, the Office of the Whistleblower, in its discretion,
may seek assistance and confirmation from the governmental/SRO entity
in making an award determination.
    (d) Once the time for filing any appeals of the final judgment or
order in a potential related action has expired, or if an appeal has
been filed, after all appeals in the action have been concluded, the
Claims Review Staff (as specified in Sec.  240.21F-10(d) of this
chapter) will evaluate all timely whistleblower award claims submitted
on Form WB-APP in connection with the related action. The evaluation
will be undertaken pursuant to the criteria set forth in these rules.
In connection with this process, the Office of the Whistleblower may
require that you provide additional information relating to your
eligibility for an award or satisfaction of any of the conditions for
an award, as set forth in Sec.  240.21F-(8)(b) of this chapter.
Following a determination by the Claims Review Staff (and an
opportunity for the Commission to review that determination), the
Office of the Whistleblower will send you a Preliminary Determination
setting forth a preliminary assessment as to whether the claim should
be allowed or denied and, if allowed, setting forth the proposed award
percentage amount.
    (e) You may contest the Preliminary Determination made by the
Claims Review Staff by submitting a written response to the Office of
the Whistleblower setting forth the grounds for your objection to
either the denial of an award or the proposed amount of an award. The
response must be in the form and manner that the Office of the
Whistleblower shall require. You may also include documentation or
other evidentiary support for the grounds

advanced in your response. In applying the award factors specified in
Sec.  240.21F-6 of this chapter and determining the award dollar and
percentage amounts set forth in the Preliminary Determination, the
award factors may be considered by the SEC staff and the Commission in
dollar terms, percentage terms or some combination thereof. Should you
choose to contest a Preliminary Determination, you may set forth the
reasons for your objection to the proposed amount of an award,
including the grounds therefore, in dollar terms, percentage terms or
some combination thereof.
    (1) Before determining whether to contest a Preliminary
Determination, you may:
    (i) Within thirty (30) days of the date of the Preliminary
Determination, request that the Office of the Whistleblower make
available for your review the materials from among those set forth in
Sec.  240.21F-12(a) of this chapter that formed the basis of the Claims
Review Staff's Preliminary Determination.
    (ii) Within thirty (30) days of the date of the Preliminary
Determination, request a meeting with the Office of the Whistleblower;
however, such meetings are not required and the office may in its sole
discretion decline the request.
    (2) If you decide to contest the Preliminary Determination, you
must submit your written response and supporting materials within sixty
(60) calendar days of the date of the Preliminary Determination, or if
a request to review materials is made pursuant to paragraph (e)(1)(i)
of this section, then within sixty (60) calendar days of the Office of
the Whistleblower making those materials available for your review.
* * * * *

0
11. Amend Sec.  240.21F-12 by:
0
a. Revising the introductory text of paragraph (a);
0
b. Amending paragraph (a)(2) by removing the parenthetical phrase
``(referenced in Sec.  249.1800 of this chapter)''; and
0
c. Revising paragraphs (a)(3) and (6).
    The revisions read as follows:

Sec.  240.21F-12  Materials that may form the basis of an award
determination and that may be included in the record on appeal.

    (a) The following items constitute the materials that the
Commission, the Claims Review Staff (as specified in Sec.  240.21F-
10(d) of this chapter), and the Office of the Whistleblower may rely
upon to make an award determination pursuant to Sec. Sec.  240.21F-21F-
10, 240.21F-11, and 240.21F-18 of this chapter:
* * * * *
    (3) The whistleblower's Form WB-APP, including attachments, any
supplemental materials submitted by the whistleblower before the
deadline to file a claim for a whistleblower award for the relevant
Notice of Covered Action, and any other materials timely submitted by
the whistleblower in response either
    (i) To a request from the Office of the Whistleblower or the
Commission; or
    (ii) To the Preliminary Determination or Preliminary Summary
Disposition that was provided to the claimant;
* * * * *
    (6) Any other documents or materials from third parties (including
sworn declarations) that are received or obtained by the Office of the
Whistleblower to resolve the claimant's award application, including
information related to the claimant's eligibility. (The Commission, the
Claims Review Staff, and the Office of the Whistleblower may not rely
upon information that the third party has not authorized the Commission
to share with the claimant.)
* * * * *

0
12. Amend Sec.  240.21F-13 by revising paragraph (b) to read as
follows:

Sec.  240.21F-13  Appeals.

* * * * *
    (b) The record on appeal shall consist of the Final Order, any
materials that were considered by the Commission in issuing the Final
Order, and any materials that were part of the claims process leading
from the Notice of Covered Action to the Final Order (including, but
not limited to, the Notice of Covered Action, whistleblower award
applications filed by the claimant, the Preliminary Determination or
Preliminary Summary Disposition, materials that were considered by the
Claims Review Staff in issuing the Preliminary Determination or that
were provided to the claimant by the Office of the Whistleblower in
connection with a Preliminary Summary Disposition, and materials that
were timely submitted by the claimant in response to the Preliminary
Determination or Preliminary Summary Disposition). The record on appeal
shall not include any pre-decisional or internal deliberative process
materials that are prepared exclusively to assist the Commission and
the Claims Review Staff (as specified in Sec.  240.21F-10(d) of this
chapter) in deciding the claim (including the staff's Proposed Final
Determination or the Office of the Whistleblower's Proposed Final
Summary Disposition, or any Draft Preliminary Determination or Draft
Summary Disposition that were provided to the Commission for review).
When more than one claimant has sought an award based on a single
Notice of Covered Action, the Commission may exclude from the record on
appeal any materials that do not relate directly to the claimant who is
seeking judicial review.

0
13. Add Sec.  240.21F-18 to read as follows:

Sec.  240.21F-18  Summary disposition.

    (a) Notwithstanding the procedures specified in Sec.  240.21F-10(d)
through (g) and in Sec.  240.21F-11(d) through (g) of this chapter, the
Office of the Whistleblower may determine that an award application
that meets any of the following conditions for denial shall be resolved
through the summary disposition process described further in paragraph
(b) of this section:
    (1) You submitted an untimely award application;
    (2) You did not comply with the requirements of Sec.  240.21F-9 of
this chapter when submitting the tip upon which your award claim is
based, and you otherwise are not eligible for a waiver under either
Sec.  240.21F-9(e) or the Commission's other waiver authorities;
    (3) The information that you submitted was never provided to or
used by the staff handling the covered action or the underlying
investigation (or examination), and those staff members otherwise had
no contact with you;
    (4) You did not comply with Sec.  240.21F-8(b) of this chapter;
    (5) You failed to specify in the award application the submission
pursuant to Sec.  240.21F-9(a) of this chapter upon which your claim to
an award is based;
    (6) Your application does not raise any novel or important legal or
policy questions.
    (b) The following procedures shall apply to any award application
designated for summary disposition:
    (1) The Office of the Whistleblower shall issue a Preliminary
Summary Disposition that notifies you that your award application has
been designated for resolution through the summary disposition process.
The Preliminary Summary Disposition shall also state that the Office
has preliminarily determined to recommend that the Commission deny the
award application and identify the basis for the denial.
    (2) Prior to issuing the Preliminary Summary Disposition, the
Office of the Whistleblower shall prepare a staff

declaration that sets forth any pertinent facts regarding the Office's
recommendation to deny your application. At the same time that it
provides you with the Preliminary Summary Disposition, the Office of
the Whistleblower shall, in its sole discretion, either
    (i) Provide you with the staff declaration; or
    (ii) Notify you that a staff declaration has been prepared and
advise you that you may obtain the declaration only if within fifteen
(15) calendar days you sign and complete a confidentiality agreement in
a form and manner acceptable to the Office of the Whistleblower
pursuant to Sec.  240.21F-8(b)(4) of this chapter. If you fail to
return the signed confidentiality agreement within fifteen (15)
calendar days, you will be deemed to have waived your ability to
receive the staff declaration.
    (3) You may reply to the Preliminary Summary Disposition by
submitting a response to the Office of the Whistleblower within thirty
(30) calendar days of the later of:
    (i) The date of the Preliminary Summary Disposition, or
    (ii) The date that the Office of the Whistleblower sends the staff
declaration to you following your timely return of a signed
confidentiality agreement. The response must identify the grounds for
your objection to the denial (or in the case of item (a)(5) of this
section, correct the defect). The response must be in the form and
manner that the Office of the Whistleblower shall require. You may
include documentation or other evidentiary support for the grounds
advanced in your response.
    (4) If you fail to submit a timely response pursuant to paragraph
(b)(3) of this section, the Preliminary Summary Disposition will become
the Final Order of the Commission. Your failure to submit a timely
written response will constitute a failure to exhaust administrative
remedies.
    (5) If you submit a timely response pursuant to paragraph (b)(3) of
this section, the Office of the Whistleblower will consider the issues
and grounds advanced in your response, along with any supporting
documentation that you provided, and will prepare a Proposed Final
Summary Disposition. The Office of the Whistleblower may supplement the
administrative record as appropriate. (This provision does not prevent
the Office of the Whistleblower from determining that, based on your
written response, the award claim is no longer appropriate for summary
disposition and that it should be resolved through the claims
adjudication procedures specified in either Sec. Sec.  240.21F-10 or
240.21F-11 of this chapter).
    (6) The Office of the Whistleblower will then notify the Commission
of the Proposed Final Summary Disposition. Within thirty (30) calendar
days thereafter, any Commissioner may request that the Proposed Final
Summary Disposition be reviewed by the Commission. If no Commissioner
requests such a review within the 30-day period, then the Proposed
Final Summary Disposition will become the Final Order of the
Commission. In the event a Commissioner requests a review, the
Commission will consider the award application and issue a Final Order.
    (7) The Office of the Whistleblower will provide you with the Final
Order of the Commission.
    (c) In considering an award determination pursuant to this rule,
the Office of the Whistleblower and the Commission may rely upon the
items specified in Sec.  240.21F-12(a) of this chapter. Further, Sec.
240.21F-12(b) of this chapter shall apply to summary dispositions.

PART 249--FORMS, SECURITIES EXCHANGE ACT OF 1934

0
14. The general authority citation for part 249 continues to read as
follows, and sectional authorities for 249.1800 and 249.1801 are
removed:

    Authority:  15 U.S.C. 78a et seq. and 7201 et seq.; 12 U.S.C.
5461 et seq.; 18 U.S.C. 1350; Sec. 953(b), Pub. L. 111-203, 124
Stat. 1904; Sec. 102(a)(3), Pub. L. 112-106, 126 Stat. 309 (2012);
Sec. 107, Pub. L. 112-106, 126 Stat. 313 (2012), and Sec. 72001,
Pub. L. 114-94, 129 Stat. 1312 (2015), unless otherwise noted.
* * * * *

Subpart S--[Removed and Reserved]

0
15. Remove and reserve Subpart S, consisting of Sec. Sec.  249.1800
through 249.1801.

    By the Commission.

    Dated: September 23, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-21444 Filed 11-4-20; 8:45 am]
 BILLING CODE 8011-01-P