The IRS has issued guidance clarifying that taxpayers receiving loans under the Paycheck Protection Program (PPP) may deduct their business expenses, even if their PPP loans are forgiven. The IRS previously issued Notice 2020-32 and Rev. Rul. 2020-27, which stated that taxpayers who received PPP loans and had those loans forgiven would not be able to claim business deductions for their otherwise deductible business expenses.

The IRS has issued guidance clarifying that taxpayers receiving loans under the Paycheck Protection Program (PPP) may deduct their business expenses, even if their PPP loans are forgiven. The IRS previously issued Notice 2020-32 and Rev. Rul. 2020-27, which stated that taxpayers who received PPP loans and had those loans forgiven would not be able to claim business deductions for their otherwise deductible business expenses.

The COVID-Related Tax Relief Act of 2020 ( P.L. 116-260) amended the CARES Act ( P.L. 116-136) to clarify that business expenses paid with amounts received from loans under the PPP are deductible as trade or business expenses, even if the PPP loan is forgiven. Further, any amounts forgiven do not result in the reduction of any tax attributes or the denial of basis increase in assets. This change applies to years ending after March 27, 2020.

Notice 2020-32, I.R.B. 2020-21, 83 and Rev. Rul. 2020-27, I.R.B. 2020-50, 1552 are obsoleted.

The IRS has waived the requirement to file Form 1099 series information returns or furnish payee statements for certain COVID-related relief that is excluded from gross income.

The IRS has waived the requirement to file Form 1099 series information returns or furnish payee statements for certain COVID-related relief that is excluded from gross income.

Reporting Affected

The IRS waives the requirement to file Form 1099 series information returns, or furnish payee statements, for the following:

• forgiveness of covered loans under the original Paycheck Protection Program (PPP);
• forgiveness of covered loans under the Paycheck Protection Program Second Draw (PPP II);
• Treasury Program loan forgiveness under section 1109 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act ( P.L. 116-136);
• certain loan subsidies authorized under section 1112(c) of the CARES Act;
• certain COVID-related student emergency financial aid grants under section 3504, 18004, or 18008 of the CARES Act or section 277(b)(3) of the COVID-related Tax Relief Act of 2020 (COVID Relief Act) (Division N, P.L. 116-260);
• Economic Injury Disaster Loan (EIDL) grants under section 1110(e) of the CARES Act or section 331 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (Economic Aid Act) (Division N, P.L. 116-260); and
• shuttered venue operator grants under section 324(b) of the Economic Aid Act.

Other Reporting

The waivers do not affect requirements to file and furnish other forms, such as forms in the 1098 series. For example, the waiver does not apply to the requirement to file and furnish Form 1098-T, Tuition Statement, for qualified tuition and related expense payments, including qualified tuition and related expenses paid with COVID-related student emergency financial aid grants. Also, because borrowers may deduct mortgage interest that the Small Business Administration paid to lenders, lenders may include those mortgage interest payments in Box 1 of Form 1098, Mortgage Interest Statement. Lenders who are unable to furnish with this information by February 1, 2021, are encouraged to furnish a corrected Form 1098 as promptly as possible.

Due to the COVID-19 pandemic, certain employers and employees who use the automobile lease valuation rule to determine the value of an employee’s personal use of an employer-provided automobile may switch to the vehicle cents-per-mile method.

Due to the COVID-19 pandemic, certain employers and employees who use the automobile lease valuation rule to determine the value of an employee’s personal use of an employer-provided automobile may switch to the vehicle cents-per-mile method.

Background

Under the general rule, an employer who provides an employee a vehicle must adopt one of the following methods to determine the value of an employee’s personal use of the vehicle: the automobile lease valuation rule, or the vehicle cents-per-mile valuation rule. (In certain cases, a third method, the commuting valuation rule, may be used.)

The employer and the employee must use the chosen valuation method consistently (that is, in each subsequent year), except that the employer and the employee may use the commuting valuation rule if its requirements are satisfied.

As a result of the pandemic, many employers suspended business operations or implemented telework arrangements for employees, thus reducing business and personal use of employer-provided automobiles, This has increased the lease value to be included in an employee’s income for 2020 compared to prior years. In contrast, the vehicle cents-per-mile valuation rule includes in income only the value that relates to actual personal use, providing a more accurate reflection of the employee’s income in these circumstances.

Switch to Cents-per-Mile

Due to the suddenness and unexpected onset of the COVID-19 pandemic, the IRS is allowing an employer that uses the automobile lease valuation rule for the 2020 calendar year to instead use the vehicle cents-per-mile valuation rule beginning on March 13, 2020, if:

• at the beginning of 2020, the employer reasonably expected that an automobile with a fair market value not exceeding $50,400 would be regularly used in the employer’s trade or business throughout the year; and
• due to the COVID-19 pandemic, the automobile was not regularly used in the employer’s trade or business throughout the year.

Employers that choose to switch from the automobile lease valuation rule to the vehicle cents-per-mile valuation rule in the 2020 calendar year must prorate the value of the vehicle using the automobile lease valuation rule for January 1, 2020, through March 12, 2020.

Employers that switch to the vehicle cents-per-mile valuation rule during 2020 generally may:

• revert to the automobile lease valuation rule for 2021; or
• continue using vehicle cents-per-mile valuation rule for 2021.

In either case, the special valuation rule used in 2021 must be used for all subsequent years.

Employees must use the same special valuation rule used by their employer.

Estimated tax underpayment penalties under Code Sec. 6654 are waived for certain excess business loss-related payments for tax years beginning in 2019. The relief is available to individuals, as well as trusts and estates that are treated as individuals for estimated tax payment penalty purposes.

Estimated tax underpayment penalties under Code Sec. 6654 are waived for certain excess business loss-related payments for tax years beginning in 2019. The relief is available to individuals, as well as trusts and estates that are treated as individuals for estimated tax payment penalty purposes.

Rules Delayed

Certain business losses were limited in tax years beginning in 2017 through 2025 by the excess business loss rules of Code Sec. 461(l). Under these rules, any disallowed excess business losses are carried forward as net operating losses (NOLs). The Coronavirus Aid, Relief, and Economic Security (CARES) Act ( P.L. 116-136) postponed application of the excess business loss rules to tax years beginning after December 31, 2020.

Relief for 2019

The relief is available only for estimated tax income tax installments due on or before July 15 2020 for a tax year that began in 2019.

An individual taxpayer may have underpaid one or more installments for the tax year that began in 2019, if the individual anticipated having a lower required annual payment after using an NOL carried forward from a prior-year excess business loss that, before the enactment of the CARES Act, would have been available to reduce taxable income in the tax year that began in 2019.

Waiver Request

To qualify for the relief, the taxpayer must:

• have filed a timely 2019 federal income tax return;
• complete the 2019 version of Form 2210, Underpayment of Estimated Taxes, or Form 2210-F, Underpayment of Tax for Farmers and Fishermen; and
• include certain required attachments and calculations.

The IRS has extended the time period during which employers must withhold and pay the employee portion of Social Security tax that employers elected to defer on wages paid from September 1, 2020, through December 31, 2020.

The IRS has extended the time period during which employers must withhold and pay the employee portion of Social Security tax that employers elected to defer on wages paid from September 1, 2020, through December 31, 2020. Specifically:

• the end date of the period for withholding and paying the deferred tax is postponed from April 30, 2021, to December 31, 2021; and
• any interest, penalties, and additions to tax for late payment of any unpaid deferred tax will begin to accrue on January 1, 2022, rather than on May 1, 2021.

Notice 2020-65, I.R.B. 2020-38, 567, is modified.

Employee Tax Deferral

In response to the coronavirus (COVID-19) disaster, President Trump issued a memorandum on August 8, 2020, directing the Treasury Secretary to use his Code Sec. 7508A authority to defer the withholding, deposit, and payment of the employee portion of the 6.2-percent old-age, survivors and disability insurance (OASDI) tax (Social Security tax) under Code Sec. 3101(a), and the Railroad Retirement Tax Act (RRTA) Tier 1 tax that is attributable to the 6.2-percent Social Security tax under Code Sec. 3201. The deferral was available only for tax on wages paid from September 1, 2020, through December 31, 2020, and only for employees whose biweekly, pre-tax pay was less than $4,000, or a similar amount where a different pay period applied.

The Treasury Secretary and the IRS then issued Notice 2020-65, directing employers that elected to apply the deferral to withhold and pay the deferred taxes ratably from wages and compensation paid between January 1, 2021, and April 30, 2021. Interest, penalties, and additions to tax would begin to accrue on May 1, 2021, on any unpaid applicable taxes.

Payment Period Extended

The recent COVID-related Tax Relief Act of 2020 (Division N, P.L. 116-260) extended the payment period, and required the Treasury Secretary to apply Notice 2020-65 by substituting "December 31, 2021" for "April 30, 2021" and substituting "January 1, 2022" for "May 1, 2021."

Employers that elected to defer employees’ payroll taxes can now withhold and pay the deferred tax throughout 2021, instead of just during the first four months of the year.

The IRS has issued guidance that provides partnerships with relief from certain penalties for the inclusion of incorrect information in reporting their partners’ beginning capital account balances on the 2020 Schedules K-1 (Forms 1065 and 8865). The IRS has also provided relief from accuracy-related penalties for any tax year for the portion of an imputed underpayment attributable to the inclusion of incorrect information in a partner’s beginning capital account balance reported by a partnership for the 2020 tax year.

The IRS has issued guidance that provides partnerships with relief from certain penalties for the inclusion of incorrect information in reporting their partners’ beginning capital account balances on the 2020 Schedules K-1 (Forms 1065 and 8865). The IRS has also provided relief from accuracy-related penalties for any tax year for the portion of an imputed underpayment attributable to the inclusion of incorrect information in a partner’s beginning capital account balance reported by a partnership for the 2020 tax year.

Penalty Relief

A partnership will not be subject to a penalty under Code Secs. 6698, 6721, or 6722 for the inclusion of incorrect information in reporting its partners’ beginning capital account balances on the 2020 Schedules K-1 if the partnership can show that it took ordinary and prudent business care in following the 2020 Form 1065 Instructions. Under those instructions, a partnership can report its partners’ beginning capital account balances using any one of the following methods: tax basis method, modified outside basis method, modified previously taxed capital method, or section 704(b) method.

In addition, a partnership will not be subject to a penalty under Code Secs. 6698, 6721, or 6722 for the inclusion of incorrect information in reporting its partners’ ending capital account balances on Schedules K-1 in tax year 2020, or its partners’ beginning or ending capital account balances on Schedules K-1 in tax years after 2020, to the extent the incorrect information is attributable solely to the incorrect information reported as the beginning capital account balance on the 2020 Schedule K-1 for which relief is provided by this guidance.

Finally, on certain conditions, the IRS will waive any accuracy-related penalty under Code Sec. 6662 for any tax year with respect to any portion of an imputed underpayment that is attributable to an adjustment to a partner’s beginning capital account balance reported by the partnership for the 2020 tax year. However, this waiver will be granted only to the extent the adjustment arises from the inclusion of incorrect information for which the partnership qualifies for relief under section 3 of this guidance.

Final regulations provide guidance related to the limitation on the deduction for employee compensation in excess of $1 million.

Final regulations provide guidance related to the limitation on the deduction for employee compensation in excess of $1 million. Specifically, the regulations address:

• what constitutes a publicly held corporation for purposes of Code Sec. 162(m)(2);
• the definition of a covered employee for purposes of Code Sec. 162(m)(3);
• the definition of compensation for purposes of Code Sec. 162(m)(4);
• the application of Code Sec. 162(m) to a taxpayer’s deduction for compensation for a tax year ending on or after a privately held corporation becomes public; and
• what constitutes a binding contract and material modification for purposes of the grandfather rule in Code Sec. 162(m)(4)(B).

The IRS has adopted the proposed regulations with a small number of modifications.

Background

The Tax Cuts and Jobs Act ( P.L. 115-97) (TCJA) modified the definitions of "covered employee," "compensation," and "publicly held corporation" for purposes of the limitation on the deduction for excessive employee compensation paid by publicly held corporations.

Publicly Held Corporations

The TCJA expanded the definition of publicly held corporation to include: (1) corporations with any class of securities and (2) corporations that are required to file reports under section 15(d) of the Exchange Act. The final regulations adopt the prosed regulation’s stance that a corporation is publicly held if, as of the last day of its tax year, its securities are required to be registered under section 12 of the Exchange Act or is required to file reports under section 15(d). A foreign private issuer (FPI) is also a publicly held corporation if it meets the same requirements.

Under the regulations, a publicly held corporation includes an affiliated group of corporations (affiliated group) that contains one or more publicly held corporations. In addition a subsidiary corporation that meets the definition of publicly held corporation is separately subject to Code Sec. 162(m) compensation limitations. Furthermore, an affiliated group includes a parent corporation that is privately held if one or more of its subsidiary corporations is a publicly held corporation. The regulations provide further clarification for affiliated groups where certain members are not publicly held. In the case where a covered employee of two or more members of an affiliated groups is paid by a member of the affiliated group that is not a publicly held, the compensation is prorated for purposes of determining the deduction.

In instances where a privately held corporation becomes public, Code Sec. 162(m) applies to the deduction for any compensation that is otherwise deductible for the tax year ending on or after the date that the corporation becomes a publicly held corporation. The regulations provide that a corporation is considered to become publicly held on the date that its registration statement becomes effective either under the Securities Act or the Exchange Act.

Covered Employees

Under the TCJA, a covered employee is the principal executive officer (PEO), the principal financial officer (PFO), or one of the three other highest compensated executives. The final regulations adopt the proposed regulation’s stance that there is no requirement that an employee must an executive officer at the end of the tax year to be a covered employee. Covered employees may include employees who have left the corporation. Furthermore, the definition applies regardless of whether the executive officer’s compensation is subject to disclosure for the last completed fiscal year under the applicable SEC rules.

The term "covered employee" also includes any employee who was a covered employee of any predecessor of the publicly held corporation for any preceding taxable year beginning after December 31, 2016. The regulations provide rules for determining the predecessor of a publicly held corporation for various corporate transactions. With respect to asset acquisitions, the regulations provide that, if an acquiror corporation acquires at least 80% of the net operating assets (determined by fair market value on the date of acquisition) of a publicly held target corporation, then the target corporation is a predecessor of the acquiror corporation for purposes of covered employees.

Applicable Employee Compensation

The final regulations define compensation as the aggregate amount allowable as a deduction for services performed by a covered employee, without regard for Code Sec. 162(m). Compensation includes payment for services performed by a covered employee in any capacity, including as a common law employee, a director, or an independent contractor. The regulations clarify that compensation also includes an amount that is includible in the income of, or paid to, a person other than the covered employee, including after the death of the covered employee.

In cases where a publicly held corporation holds a partnership, it must:

• take into account its distributive share of the partnership’s deduction for compensation paid to the publicly held corporation’s covered employee and
• aggregate that distributive share with the corporation’s otherwise allowable deduction for compensation paid directly to that employee in applying the Code Sec. 162(m) deduction limitation.

Grandfather Rules

The amendments made by the TCJA to Code Sec. 162(m) do not apply to any compensation paid under a written binding contract that is effect on November 2, 2017, and is not materially modified after that date. A contract is binding if it obligates a publicly held company to pay the compensation if the employee performs services or satisfies requirements in the contract. Under the final regulations:

• The TCJA amendments apply to any amount of compensation that exceeds the amount that applicable law obligates the corporation to pay under a written binding contract that was in effect on November 2, 2017.
• A provision in a compensation agreement that purports to give the employer discretion to reduce or eliminate a compensation payment (negative discretion) is taken into account only to the extent the corporation has the right to exercise that discretion under applicable law, such as state contract law.
• Under an ordering rule, the grandfathered amount is allocated to the first otherwise deductible payment paid under the arrangement, then to the next otherwise deductible payment, etc. For tax years ending before December 20, 2019, the final regulations allow the grandfathered amount to be allocated to the last otherwise deductible payment or to each payment on a pro rata basis.
• A material modification occurs when a contract is amended to increase the amount of compensation payable to the employee. However, a modification that defers compensation is not a material modification if any compensation that exceeds the original amount based on a reasonable rate of interest or a predetermined actual investment.

The final regulations depart from the proposed regulations with respect to the recovery of compensation. Under the proposed regulations, a corporation’s right to recover compensation is disregarded in determining the grandfathered amount only if the corporation recovery right or obligation depends on a future condition that is objectively outside of the corporation’s control. However, the final regulations recognize that a recovery right is a contractual right that is separate from the corporation’s binding obligation to pay the compensation. Accordingly, the final regulations provide that the corporation’s right to recover compensation does not affect the determination of the amount of compensation the corporation has a written binding contract to pay under applicable law as of November 2, 2017.

The final regulations also clarify the application of the grandfather rule to compensation payable under nonqualified deferred compensation (NQDC) plans. Specifically, the grandfathered amount under an is the amount that the corporation is obligated to pay under the terms of the plan as of November 2, 2017. The regulations also provide rules for calculating the grandfather amount for account balance plans, and analogous rules for nonaccount balance plans when:

• the corporation is obligated to pay the employee the account balance that is credited with earnings and losses and has no right to terminate or materially amend the contract;
• the terms of a plan that is a written binding contract as of November 2, 2017, provide that the corporation may terminate the plan and distribute the account balance to the employee; or
• the plan provides that the corporation may not terminate the contract, but may discontinue future contributions and distribute the account balance.

However, the corporation may instead elect to treat the account balance as of the termination or freeze date as the grandfathered amount regardless of when the amount is paid and regardless of whether it has been credited with earnings or losses prior to payment.

In addition, the final regulations provide that all compensation attributable to the exercise of a non-statutory stock option or a stock appreciation right (SAR) is grandfathered if the option or SAR is grandfathered and the extension satisfies Reg. §1.409A-1(b)(5)(v)(C)(1).

Effective Dates

Generally, these final regulations apply to taxable years beginning on or after the date that they are published as final in the federal register. However, taxpayers may choose to apply these final regulations to a taxable year beginning after December 31, 2017. Taxpayers that elect to apply the final regulations before the effective date must apply the final regulations consistently and in their entirety to that taxable year and all subsequent taxable years.

In addition, the final regulations include special applicability dates for certain aspects of the definition of:

• a covered employee,
• a predecessor of a publicly held corporation,
• compensation, and
• a written binding contract and material modification.

The regulations also include a special applicability date for the application of the Code Sec. 162(m) deduction limitations deductible for a taxable year ending on or after a privately held corporation becomes a publicly held corporation.

The IRS has issued final regulations providing additional guidance on the limitation on the deduction for business interest under Code Sec. 163(j). The regulations finalize various portions of the proposed regulations issued in 2020 with few modifications. They address the application of the limit in the context of calculating adjusted taxable income (ATI) with respect to depreciation, amortization, and depletion. The regulations also finalize rules on the definitions of real property development and redevelopment, as well as application to passthrough entities, regulated investment companies (RICs), and controlled foreign corporations.

The IRS has issued final regulations providing additional guidance on the limitation on the deduction for business interest under Code Sec. 163(j). The regulations finalize various portions of the proposed regulations issued in 2020 with few modifications. They address the application of the limit in the context of calculating adjusted taxable income (ATI) with respect to depreciation, amortization, and depletion. The regulations also finalize rules on the definitions of real property development and redevelopment, as well as application to passthrough entities, regulated investment companies (RICs), and controlled foreign corporations.

Calculating ATI

A taxpayer’s ATI for purposes of the Section 163(j) limit is the taxpayer’s tentative taxable income for the tax year with certain adjustments. For example, depreciation, amortization, and depletion for tax years beginning before January 1, 2022, is added back to tentative taxable income, but is subtracted from tentative taxable income if the taxpayer sells or disposes the property before January 1, 2022.

The final regulations provide that a taxpayer has the option to use an alternative computation method for property dispositions where the ATI adjustment is the lesser of: (1) any gain recognized on the sale or disposition; or (2) the greater of the allowed or allowable depreciation, amortization, or depletion deduction of the property sold before January 1, 2022.

Similar rules apply for the sale or other disposition of an interest in a partnership or stock of a member of a consolidated group. However, the negative adjustment to tentative taxable income is reduced to the extent the taxpayer establishes that the additions to tentative taxable income in a prior tax year did not result in an increase in the amount allowed as a deduction for business interest expense for the year.

Real Property Development

The Section 163(j) limit does not apply to certain excepted trades or businesses, including an electing real property trade or business. An electing real property trade or business is any trade or business described in Code Sec. 469(c)(7)(C).

In response to comments about the application of this definition to timberlands, the 2020 proposed regulations provided definitions for real property development and redevelopment for clarity relying on the Code Sec. 464(e) definition of farming for that purpose. Section 464(e) generally excludes the cultivation and harvesting of trees (except those bearing fruit or nuts) from the definition of "farming".

The final regulations retain these definitions for real property development and real property redevelopment. Thus, to the extent the evergreen trees may be located on parcels of land covered by forest, the business activities of cultivating and harvesting such evergreen trees are a component of a "real property development" or "real property redevelopment" trade or business.

Self-Charged Lending

The final regulations adopt the proposed rules for self-charged lending transactions between partners and partnerships without change. For a transaction between a lending partner and a borrowing partnership in which the lending partner owns a direct interest, any business interest expense of the borrowing partnership attributable to a self-charged lending transaction is business interest expense of the borrowing partnership.

However, to the extent the lending partner receives interest income attributable to the self-charged lending transaction and also is allocated excess business interest in the same tax year, the lending partner may treat that interest income as an allocation of excess business income from the borrowing partnership to the extent of the lending partner’s allocation of excess business interest expense.

The IRS has released final regulations that address the changes made to Code Sec. 162(f) by the Tax Cuts and Jobs Act (TCJA) ( P.L. 115-97), concerning the deduction of certain fines, penalties, and other amounts. The final regulations also provide guidance relating to the information reporting requirements for fines and penalties under Code Sec. 6050X.

The IRS has released final regulations that address the changes made to Code Sec. 162(f) by the Tax Cuts and Jobs Act (TCJA) ( P.L. 115-97), concerning the deduction of certain fines, penalties, and other amounts. The final regulations also provide guidance relating to the information reporting requirements for fines and penalties under Code Sec. 6050X.

The final regulations adopt proposed regulations released last May ( NPRM REG-104591-18), with modifications.

TCJA Changes

Under changes made to Code Sec. 162(f) by the TCJA, businesses may not deduct fines and penalties paid or incurred after December 21, 2017, due to the violation of a law (or the investigation of a violation) if a government (or similar entity) is a complainant or investigator. Exceptions to this rule are available if the payment was for restitution, remediation, taxes due, or paid or incurred to come into compliance with a law. For the exceptions to apply, the taxpayer must identify the payment as restitution, remediation, or compliance in a court order or settlement agreement. In addition, Code Sec. 6050X now requires the officer or employee that has control over the suit or agreement to file a return with the IRS

The final regulations establish that a taxpayer generally may not take a deduction for any amount that was paid or incurred:

• by suit, agreement, or otherwise;
• to, or at the direction of, a government or governmental entity; and
• in relation to the violation, or investigation or inquiry by the government or governmental entity into the potential violation, of any civil or criminal law.

This rule applies regardless of whether the taxpayer admits guilt or liability, or pays the amount imposed for any other reason. This includes instances where the taxpayer pays to avoid the expense or uncertain outcome of an investigation or litigation.

The final regulations also clarify that a suit or agreement is treated as binding under applicable law even if all appeals have not been exhausted.

Governmental Entities

Under the final regulations, governmental entities include nongovernmental entities that exercise self-regulatory powers, including imposing sanctions.

The regulations also clarify that, for purposes of the information reporting requirements in Code Sec. 6050X, a nongovernmental entity treated as a governmental entity does not include a nongovernmental entity of a territory of the United States, including American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, or the U.S. Virgin Islands, a foreign country, or a Native American tribe.

Violations of Law

Under the final regulations, violations of the law do not include any order or agreement in a suit in which a government or governmental entity enforces rights as a private party.

Investigations

The final regulations also make clear that amounts paid or incurred for required routine investigations or inquiries continue to be deductible. In general, amounts paid or incurred for routine investigations or inquiries, such as audits or inspections, required to ensure compliance with rules and regulations applicable to the business or industry, which are not related to any evidence of wrongdoing or suspected wrongdoing, are not amounts paid or incurred relating to the potential violation of any law.

Establishing Payment

Under the final regulations, a taxpayer can establish that a payment was made for restitution or remediation by providing documentary evidence of the following:

• the taxpayer was legally obligated to pay the amount that the order or agreement identified as restitution, remediation, or to come into compliance with a law;
• the amount paid or incurred for the nature and purpose identified; and
• the date on which the amount was paid or incurred.

The final regulations expand the list of documentary evidence that may be used to meet the establishment requirement. According to the regulations, taxpayers may be able to use documentary evidence in a foreign language to satisfy the establishment requirement if the taxpayer provides a complete and accurate certified English translation of the documentary evidence.

Reporting of the amount by a government or governmental entity under Code Sec. 6050X alone does not satisfy the establishment requirement.

Disgorgement, Forfeiture of Profits

Under the final regulations, a taxpayer’s claim for a deduction for amounts paid or incurred through disgorgement or forfeiture of profits will be permitted if:

• the amount is otherwise deductible;
• the order or agreement identifies the payment, not in excess of net profits, as restitution, remediation, or an amount paid to come into compliance with a law;
• the taxpayer establishes that the amount was paid as restitution, remediation, or an amount paid to come into compliance with a law; and
• the origin of the taxpayer’s liability is restitution, remediation, or an amount paid to come into compliance with a law.

However, amounts paid or incurred through disgorgement will be disallowed if the amounts are disbursed to the general account of the government or governmental entity for general enforcement efforts or other discretionary purposes.

Restitution, Remediation

Final Reg. §1.162-21(e)(4)(i) clarifies that restitution and remediation do not include amounts paid to a general account or for discretionary purposes. In addition, the final regulations provide that if amounts paid by the taxpayer pursuant to an order or an agreement is returned, the taxpayer must include the amount in its income under the tax benefit rule.

Reg. §1.162-21(e)(4)(i)(A) also provides special restitution and remediation rules to address amounts paid or incurred for irreparable harm to the environment, natural resources, or wildlife.

Coming into Compliance

The final regulations list certain payments that will not be treated as “paid or incurred to come into compliance with a law.” In addition, the taxpayer must perform any required services or take any required action in order to come into compliance with the law.

The final regulations also modify an example to clarify that when a taxpayer upgrades equipment or property to a higher standard than what is required to come into compliance with the law, the taxpayer will be able to deduct the difference between what the taxpayer paid and the amount required to come into compliance.

Identification

Under Code Sec. 162(f)(2)(A), an order or agreement must identify the amount paid or incurred as restitution, remediation, or to come into compliance with a law. The final regulations modify the proposed rule for payment amounts not identified. Under this rule, the identification requirement may be met even if the order or agreement does not allocate the total lump-sum payment amount among restitution, remediation, or to come into compliance with the law. The rule also applies when the order or agreement fails to allocate the total payment among multiple taxpayers. In addition, the final regulations clarify that the identification requirement may be met even in cases where the order or agreement does not provide an estimated payment amount.

Consistent with Code Sec. 162(f)(2)(A)(ii), the final regulations provide that the order or agreement, not the taxpayer, must meet the identification requirement with language specifically stating or describing that the amount will be paid or incurred as restitution, remediation, or to come into compliance with a law.

The final regulations eliminated the rebuttable presumption for the identification requirement. Instead, the identification requirement is met when the order or agreement specifically states that the payment constitutes restitution, remediation, or an amount paid to come into compliance with a law, or when it uses a different form of the required words. For orders or agreements in a foreign language, in order to meet the identification requirement the taxpayer must provide a complete and accurate certified English translation that describes the nature and purpose of the payment using the foreign language equivalent of restitution, remediation, or coming into compliance with the law.

According to the final regulations, an order or agreement will also meet the identification requirement if it describes the damage done, harm suffered, or manner of noncompliance with a law, and describes the action required of the taxpayer to (1) restore the party, property, or environment harmed or (2) perform services, take action, or provide property to come into compliance with that law.

Taxes and Interest

Under Code Sec. 162(f)(4), taxpayers may still deduct any taxes due, including any related interest on the taxes. However, the final regulations clarify that if penalties are imposed with respect to otherwise deductible taxes, a taxpayer may not deduct the penalties or the interest paid with respect to such penalties.

Multiple Payors

The final regulations address situations where there are multiple payors and the aggregate amount they are required to pay, or the costs to provide the property or the service, meets or exceeds the threshold amount. In those instances, the appropriate official should file an information return and furnish a written statement for the separate amount that each individually liable payor is required to pay, even if a payor’s payment liability is less than the threshold amount.

Material Change

According to the TCJA, the amendments to Code Sec. 162(f) apply to agreements entered into on or after December 22, 2017. However, the proposed regulations clarified that if the parties to an agreement that was binding prior to December 22, 2017, make a material change to that agreement on or after the date that the proposed regulations become final, the regulations will apply to the agreement. The final regulations have eliminated that requirement.

Reporting Requirements

The final regulations provide that if the aggregate amount a payor is required to pay equals or exceeds the threshold amount of $50,000 under Reg. §1.6050X-1(f)(6), the appropriate official of a government or governmental entity must file an information return with the IRS with respect to the amounts or incurred paid and any additional information required. That information includes:

• the amounts paid or incurred pursuant to the order or agreement;
• the payor’s taxpayer identification number (TIN); and
• other information required by the information return and the related instructions.

The official must provide this information by filing Form 1098-F, Fines, Penalties, and Other Amounts, with Form 1096, Annual Summary and Transmittal of U.S. Information Returns, on or before the annual due date. However, the regulations do not require an appropriate official to file information returns for each tax year in which a payor makes a payment pursuant to a single order or agreement. Instead, the appropriate official should only one information return for the aggregate amount identified in the order or agreement.

In instances where the final amount is unknown but is expected to meet or exceed the $50,000 threshold amount, the appropriate official should report the threshold amount on Form 1098-F.

The appropriate official must also furnish a written statement with the same information to the payor. They can satisfy this requirement by providing a copy of Form 1098-F. This statement must be provided by January 31 of such year.

Effective Date

The final regulations apply to tax years beginning on or after the date of publication in the Federal Register. The final regulations under Reg. §1.6050X-1 apply only to orders and agreements, pursuant to suits and agreements, that become binding under applicable law on or after January 1, 2022.

The IRS has provided a safe harbor allowing a trade or business that manages or operates a qualified residential living facility to be treated as a "real property trade or business" solely for purposes of qualifying to make the Code Sec. 163(j)(7)(B) election. This guidance formalizes the proposed safe harbor issued in Notice 2020-59, I.R.B. 2020-34, 782. Taxpayers may apply the rules to tax years beginning after December 31, 2017.

The IRS has provided a safe harbor allowing a trade or business that manages or operates a qualified residential living facility to be treated as a "real property trade or business" solely for purposes of qualifying to make the Code Sec. 163(j)(7)(B) election. This guidance formalizes the proposed safe harbor issued in Notice 2020-59, I.R.B. 2020-34, 782. Taxpayers may apply the rules to tax years beginning after December 31, 2017.

Qualified Residential Living Facilities

A facility is deemed to be a "qualified residential living facility" if it:

• consists of multiple rental dwelling units within one or more buildings or structures that generally serve as primary residences on a permanent or semi-permanent basis to individual customers or patients;
• provides supplemental assistive, nursing, or other routine medical services;
• has an average period of customer or patient use of individual rental dwelling units of 30 days or more; and
• retains books and records to substantiate requirements.

Further, taxpayers must use the Code Sec. 168(g) alternative depreciation system to depreciate the property under Code Sec. 168(g)(8).

Taxpayers satisfying the requirements of the safe harbor after a deemed cessation of the electing trade or business will have their initial election under Code Sec. 163(j)(7)(B) automatically reinstated.

The IRS has released final regulations addressing the post-2017 simplified accounting rules for small businesses. The final regulations adopt and modify proposed regulations released in August 2020.

The IRS has released final regulations addressing the post-2017 simplified accounting rules for small businesses. The final regulations adopt and modify proposed regulations released in August 2020.

Implementation of the Rules

The Tax Cuts and Jobs Act ( P.L. 115-97) put in place a single $25 million gross receipts test for determining whether certain taxpayers qualify as small taxpayers that can use the cash method of accounting, are not required to use inventories, are not required to apply the Uniform Capitalization (UNICAP rules), and are not required to use the percentage of completion method for a small construction contract.

Highlights of Changes in the Final Regulations

Annual syndicate election. The proposed regulations permit a taxpayer to elect to use the allocated taxable income or loss of the immediately preceding tax year to determine whether the taxpayer is a syndicate under Code Sec. 448(d)(3) for the current tax year. Under the proposed regulations, a taxpayer that makes this election must apply the rule to all subsequent tax years, unless it receives IRS permission to revoke the election.

The final regulations provide additional relief by making the election an annual election. The election is valid only for the tax year for which it is made, and once made, cannot be revoked. The IRS intends to issue procedural guidance to address the revocation of an election made under the proposed regulations as a result of the application of the final regulations.

Five-year written consent requirement relaxed. The proposed regulations require a taxpayer that meets the gross receipts test in the current tax year to obtain the written consent of the Commissioner before changing to the cash method if the taxpayer had previously changed its overall method from the cash method during any of the five tax years ending with the current tax year. The final regulations remove the 5-year restriction on making automatic accounting method changes for certain situations.

Other changes. Additional changes include the following:

• To reduce confusion about the nature of property treated as non-incidental materials and supplies under Code Sec. 471(c)(1)(B)(i), the final regulations refer to the method under that provision as the "section 471(c) NIMS inventory method."
• The final regulations provide that inventory costs includible in the section 471(c) NIMS inventory method are direct material costs of the property produced or the costs of property acquired for resale.
• Examples are added to clarify the principle that a taxpayer may not ignore its regular accounting procedures or portions of its books and records under the non-AFS section 471(c) inventory method.
• The final regulations clarify how a taxpayer treats costs to acquire or produce tangible property that the taxpayer does not capitalize in its books and records.

Applicability Date

The final regulations are applicable for tax years beginning on or after the date of publication in the Federal Register. However, a taxpayer may apply the final regulations under a particular Code provision for a tax year beginning after December 31, 2017, if the taxpayer follows all the applicable rules contained in the regulations that relate to that Code provision for the tax year and all subsequent tax years, and follows the administrative procedures for filing a change in method of accounting.

As 2013 draws closer, news reports about “taxmageddon” and “taxpocalypse,” describing expiration of the Bush-era tax cuts, are proliferating. Many taxpayers are asking what they can do to prepare. The answer is to prepare early. September may seem too early to be discussing year-end tax planning, but the uncertainty over the Bush-era tax cuts, incentives for businesses, and much more, requires proactive strategizing. Ultimately, the fate of these tax incentives will be resolved; until then, taxpayers need to be flexible in their year-end tax planning.

As 2013 draws closer, news reports about “taxmageddon” and “taxpocalypse,” describing expiration of the Bush-era tax cuts, are proliferating. Many taxpayers are asking what they can do to prepare. The answer is to prepare early. September may seem too early to be discussing year-end tax planning, but the uncertainty over the Bush-era tax cuts, incentives for businesses, and much more, requires proactive strategizing. Ultimately, the fate of these tax incentives will be resolved; until then, taxpayers need to be flexible in their year-end tax planning.

Individuals

In less than three months, the individual income tax rates are scheduled without further action to automatically increase across-the-board, with the highest rate jumping from 35 percent to 39.6 percent. Additionally, the current tax-favorable capital gains and dividends tax rates are scheduled to expire. Higher income taxpayers will also be subject to revived limitations on itemized deductions and their personal exemptions. The child tax credit, one of the most popular incentives in the tax code, will be cut in half. Millions of taxpayers are predicted to be liable for the alternative minimum tax (AMT) because of expiration of the AMT “patch.” Countless other incentives for individuals will either disappear or be substantially reduced after 2012.

In July, the House and Senate passed competing bills to extend many of these expiring incentives one more year (through 2013). No further action is expected on these bills until after the November elections. However, they do signal a highly probable temporary solution to the fate of the Bush-era tax cuts. Regardless of which party wins the White House and Congress, the probability of a one-year extension of the Bush-era tax cuts appears high.

Along with expiration of the Bush-era tax cuts, the two percent payroll tax holiday for 2012 is scheduled to expire. For individuals with income at or above the Social Security wage base for 2012 ($110,100), the payroll tax holiday represented a $2,202 savings. Unlike the Bush-era tax cuts, an extension of the payroll tax holiday is unlikely.

Putting aside the Bush-era tax cuts and the payroll tax holiday for a moment, two new taxes are scheduled to take effect after 2012: an additional 0.9 percent Medicare tax on wages and self-employment income and a 3.8 percent Medicare contribution tax on unearned income. Both new taxes are targeted to individuals with incomes over $200,000 (families with incomes over $250,000). One important misconception about the 3.8 percent Medicare tax is that it is a direct real estate tax. Taxpayers that dispose of real estate may be exempt from the tax either because of income limitations or because of an exclusion provided for primary residence home sales. However, certain high-end homes may feel the sting of the 3.8 percent tax on some or all of the gain realized. Despite some rumblings in the GOP-controlled House, it is unlikely the new Medicare taxes will be repealed before 2013.

All these provisions can be seen as the perfect storm. Year-end tax planning takes on new urgency because of the uncertainty. Some variations on traditional year-end planning techniques may be valuable. Instead of shifting income into a future year, taxpayers may want to recognize income in 2012, when lower tax rates are available, rather than shift income to 2013. The same strategy may apply to recognizing income from capital gains and dividends. Another valuable year-end strategy is to “run the numbers” for regular tax liability and AMT liability. Taxpayers may want to explore if certain deductions should be more evenly divided between 2012 and 2013, and which deductions may qualify, or will not be as valuable, for AMT purposes. Additionally, keep in mind the new Medicare taxes and how they will impact investments and possibly home sales.

Estate tax planning is also in flux. Under current law, the maximum estate tax rate is 35 percent with an applicable exclusion amount of $5 million (indexed for inflation) for decedents dying before January 1, 2013. Unless Congress acts, the estate tax will revert to its less generous pre-2001 rates. Gift and generation-skipping transfer (GST) taxes also will revert to their pre-2001 rates.

Businesses

Businesses are also confronted with uncertainty in tax planning as 2012 ends. Special incentives, such as bonus depreciation, enhanced Code Sec. 179 expensing and a host of business tax extenders, may be unavailable after 2012.

Under current law, 50-percent bonus depreciation applies to qualified property acquired and placed in service after December 31, 2011 and before January 1, 2013 (January 1, 2014 for certain property). For tax years beginning in 2012, the Code Sec, 179 expensing dollar limitation is $139,000 and the investment ceiling is $560,000 for tax years beginning in 2012. After 2012, 50-percent bonus depreciation is scheduled to expire (except for certain property) and the Code Sec. 179 expensing dollar limitation will drop to $25,000 with a $200,000 investment ceiling.

Enhanced Code Sec. 179 expensing is a good candidate for extension after 2012, but at less generous amounts. In July, the Senate approved a Code Sec. 179 dollar amount of $250,000 and an $800,000 investment limitation for tax years beginning after December 31, 2012. The House approved a Code Sec. 179 dollar amount of $100,000 and a $400,000 investment limitation after 2012.

The list of expired business tax extenders is long. The expired incentives include the research tax credit, special expensing for film and television productions, the employer wage credit for military reservists, and many more. A host of related energy incentives have also expired and are awaiting renewal. Unlike past years, Congress is not expected to routinely extend all of the expired provisions. The more widely utilized incentives are likely to be extended; some lesser used incentives may not.

Businesses do have some good news in year-end planning. Temporary “repair” regulations issued in late 2011 include a valuable de minimis rule, which could enable taxpayers to expense otherwise capitalized tangible property. Qualified taxpayers may claim a current deduction for the cost of acquiring items of relatively low-cost property, including materials and supplies, if specific requirements are met. The aggregate cost which may be expensed annually under a taxpayer’s expensing policy is subject to a ceiling equal to the greater of 0.1 percent of gross receipts or two percent of total depreciation and amortization reported on the financial statement.

Businesses should also explore the Code Sec. 199 domestic production activities deduction. This deduction, unlike many other incentives, is permanent and will not expire after 2012. The deduction allows qualified taxpayers to deduct an amount equal to the lesser of a phased-in percentage of taxable income (adjusted gross income for individuals) or qualified production activities income. A taxpayer’s Code Sec. 199 deduction cannot exceed one-half (50 percent) of the W-2 wages paid by the taxpayer during the year.

Sequestration

The fate of the Bush-era tax cuts and the other incentives is linked to sequestration. The Budget Control Act of 2011 imposes across-the-board spending cuts starting in 2013. Many lawmakers want to postpone or repeal the spending cuts but savings must be recouped somehow. Several energy tax incentives, especially for oil and gas producers, have been viewed as likely candidates for elimination to offset repeal of the Budget Control Act.

Please contact our office if you have any questions about the incentives we discussed and how you can develop a year-end tax plan that responds to the current climate of uncertainty.

Form 8942 will also contain a Penalties of Perjury Statement. Each applicant must sign and date this statement. The person signing for the applicant must have personal knowledge of the facts. Further, the declaration must be signed by a person authorized to bind the applicant. The Penalties of Perjury statement is effective for ALL information submitted as a complete application. The Project Information Memorandum: •The Department of Health and Human Services (HHS) will review information provided by the applicant in the Project Information Memorandum in order to determine whether a project meets the definition of “qualifying therapeutic discovery project” and whether the applicant has demonstrated that its project shows a “reasonable potential” to meet one or more of the goals specified in the statute. •The Project Information Memorandum must follow the format specified herein. It must contain the questions specified and the answers as to which the applicant must check yes or no. The form also requires, as stated, that the applicant provide written narratives with respect to certain questions, including narratives supporting and explaining the basis for each yes answer. The statements included in Project Information Memorandum shall not exceed the stated word limits. If statements exceed the stated word limits, words beyond those limits will not be considered. Statements that otherwise fails to comply with the instructions set out in the application will not be considered. All text shall be typed, single spaced, suing 12 point font, 1 inch margins and unreduced 8 ½ inch by 11 inch pages (A Project Information Memorandum that is submitted using the form provided on the IRS website will be deemed in compliance with spacing, font, margins and page size requirements with regard to the information submitted on such form). All applications shall be legible. Pages shall be sequentially numbered and identified with the name of the applicant and the date. No material may be incorporated in any application by reference. •Note: Any language beyond any word limits in the application will be disregarded for purposes of review. •If elements of the Project Information Memorandum contain information the applicant considers to be trade secrets, confidential, privileged or otherwise exempt from disclosure under the Freedom of Information Act, the applicant shall assert a claim of exemption at the time of application by placing the following text on the first page of the Project Information Memorandum, and specify the page or pages of the application to be restricted. “The data contained in pages [ ] of this document which hereby forms a part of the application have been submitted in confidence and contain trade secrets or proprietary information, and such data shall be used or disclosed only for review purposes. This restriction does not limit the government’s right to use or disclose data obtained without restriction from any source, including the applicant.” •To further protect trade secret, confidential, privileged or otherwise exempt information, each line or paragraph on the page or pages containing such data must be specifically identified and marked with text that is similar to the following: “The following contains proprietary information that [name of applicant] requests not to be released to persons outside of the Government, except for purposes of review.” •Note: Any text used to protect confidentiality will not be counted against the total word limits of the Project Information Memorandum. •The Project Information Memorandum must include: A.Provide an overview of the project for which you are seeking a credit or grant, including a description of the product, process or technology under development. The description may not exceed 250 words. If the project involves a new therapy, the description must include an explanation of why that therapy is novel. B.Answer each “Yes or No Question” (the actual form will have check-boxes) in the following and provide a short (not more than 50 words) statement supporting each positive assertion. Check all that apply, but you need check only one Yes for answers 1 through 4 for initial qualification.

Qualifying Therapeutic Discovery Project definition 1. Is the project: a.designed to develop a product to treat or prevent a disease or condition; b.by conducting pre-clinical activities, clinical trials, or clinical studies, or by carrying out research protocols; and c.for the purpose of securing approval of a product under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act? 2. Is the project designed to diagnose a disease or condition? 3. Is the project designed to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions? 4. Is the project designed to develop a product, process, or technology to further the delivery or administration of therapeutics? Selection criteria 5. Is the project likely to result in one or more new therapies? 6. If the answer to question 5 is Yes, are the new therapy(ies) expected to: a. treat areas of unmet medical need? b. prevent, detect, or treat chronic or acute diseases or conditions? 7. Is the project likely to reduce long-term health care costs in the United States? 8. Is the project likely to significantly advance the goal of curing cancer within the next 30 years? For each of questions 9, 10, and 11, provide a short statement, not to exceed a total of 250 words, including responses to bulleted items. For question 9, applicants may also submit up to five literature citations in the specified format that will not be counted against the 250-word limit. 9. Explain the scientific rationale, based on prior conceptual and empirical work, which supports the belief that the proposed project will lead to the outcome the applicant has identified above. Explain the research and development plan that will lead to the outcome identified above. Describe the scientific evidence relied on by the applicant, including a description of any peer review of the project and a list of no more than five literature citations using the following format: ?Include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication.

?When citing articles that were authored or co-authored by the applicant and arose from NIH support, if available, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the Pubmed Central (PMC) reference number (e.g., PMCID234567) for each citation.

?Citations for which an NIH Manuscript Submission reference number is not available but are publicly available in a free, online format should include URLs or PMCID numbers along with the full reference. The references should be limited to relevant and current literature.

10. Describe the stage of development of the project, including a description of preclinical and clinical trial results that are relevant to the proposal. Include in your description:

?If the project involves the development of a product that is regulated by the Food and Drug Administration, an explanation of whether an investigational new drug application or an investigational device exemption has been filed with the Food and Drug Administration, and whether an application for approval, license, or clearance has been filed, and, if so, the status of that application as of the date of application as of the date this project information memorandum is submitted.

?If the project does not involve the development of a product that is regulated by the Food and Drug Administration, information about any regulatory reviews or approvals that have occurred.

?If the project involves preclinical testing, a description of the testing completed and/or contemplated.

?If the project involves testing in humans, information about the phase(s) of the testing that has been completed and the number of subjects tested in each phase and information about trials for which the applicant is actively recruiting subjects. Summarize the results of the trails, noting any failed trials or successful trials.

?The planned research and development strategy for the test or treatment being researched and a summary schedule for development of the project, including timelines and milestones planned and completed.

11. Describe the resources, management experience and organizational capacity of the applicant and explain how applicant believes that such resources, experience and capacity will support successful completion of the project. Include in this description: ?A statement of the revenue levels and sources for this project over the past three years.

?A statement of the revenue levels and sources for the proposed research and development plan delineated in response to question 10.

?A description of any significant public or private investment, such as by venture capitalists, in the development or commercialization of the project.

?A description of any strategic partnerships for the development or commercialization of the project.

?A statement of whether the applicant has suspended operations for the project and, if so, whether the suspension is temporary or permanent. If the project has been suspended, terminate, or is otherwise inactive, explain why, including whether the cause is a lack of financial resources or other reasons.

Evaluation Criteria and Factors for the Project Information Memorandum HHS will make the determination described above based on the information provided in the Project Information Memorandum and on the following eligibility and evaluation criteria and factor Definitions A project that does not meet the definition of "qualifying therapeutic discovery project" will be found to be ineligible. A project that does not support an affirmative response to any of questions 1 – 4 does not meet the statutory definition of a qualifying therapeutic discovery project. The applicant must effectively support each yes answer through the accompanying narrative. Question 1 focuses on the requirement of § 48D(c)(1)(A) of the Code. To satisfy this provision, the project must be designed to treat or prevent diseases or conditions. It must be designed to do so by conducting pre-clinical activities, clinical trials, or clinical studies or carrying out a clinical protocol. It must also be for the purpose of obtaining approval of a product under one of two statutory provisions—Section 505(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (a new drug application) or Section 351(a) of the Public Health Service Act (PHSA) (a biologic license application) . For example, a medical countermeasure against a known threat or emerging infectious disease that is developed for the purpose of securing approval under one of these provisions would satisfy this provision. Note that generic drugs, which are approved under Section 505(j) of the FFDCA, and biosimilar products, which are approved under Section 351(k) of the PHSA, would be excluded. Dietary supplements and most cosmetics would also be excluded because they are generally not the subject of a new drug or biologic license application. Questions 2 and 3 focus on the requirements of § 48D(c)(1)(B) of the Code. This provision covers two separate categories of products. The first, covered by question 2, is a product to diagnose a disease or condition. Any product that diagnoses a disease or condition would meet this criterion, whether or not it determines molecular factors or is a molecular diagnostic. Relevant products would include point of care diagnostics for infectious agents. Question 3 covers a product that determines molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions. This might include, for example, a test that would determine which patients with a particular disease or condition would be likely to respond best to a particular drug or device. Question 4 focuses on the requirement of § 48D(c)(1)(C) of the Code. To qualify under question 4, a product, process, or technology must further the delivery or administration of therapeutics. For the purposes of § 48D(c)(1)(C), the term “therapeutics” means drugs or medical devices, as those terms are defined in Section 201(g) and (h) of the FFDCA, 21 U.S.C. 321(g) and (h). Biologics that are licensed under the PHSA will generally be either drugs or medical devices. Thus, a drug-eluting stent or infusion pump would be an example of a product that furthers the delivery or administration of a drug and would meet the requirements of this provision. However, a medical device, or other product, process or technology that does not further the delivery or administration of a drug or medical device would not meet the requirements of this provision because such products do not deliver or administer a therapeutic within the meaning of § 48D(c)(1)(C). The term “therapeutic” is narrower than the term “therapy,” which appears elsewhere in section 48D. Therefore, products, processes or technologies that deliver other therapies which are not therapeutics, such as speech, physical, and cognitive therapies, would for the same reasons be excluded. Reasonable potential selection criteria If HHS determines that a project meets the definition of "qualifying therapeutic discovery project," HHS will proceed to determine whether the applicant has demonstrated, through responses to questions 5-11, that its project shows a reasonable potential to meet a statutory goal. This determination will be based on an evaluation of whether the project is designed to achieve one or more of the goals specified in section 48D and, if so, whether the applicant has shown a reasonable potential to achieve the goal(s). Specifically, the applicant must show that its project is designed to achieve one of the statutory goals by checking yes for one or more of the following: a. question 5 and question 6.a; b. question 5 and question 6.b; c. question 7; or d. question 8. In addition, the applicant must effectively support each yes answer through the accompanying narrative. Question 5 addresses the requirement of § 48D(d)(3)(A)(i) of the Code that, to satisfy the statutory goal of that provision, the project must be a “new therapy.” Thus, the therapy must be novel and cannot be the same as, or difficult to meaningfully distinguish from, a therapy currently on the market. For example, this means the therapy should not be in the same class as existing therapies, unless such therapy is expected to offer a significant enhancement in safety or effectiveness. HHS will evaluate the information provided as to the novelty of the product based on the explanation provided with any Yes response to this question and the initial narrative description of the project. Question 6 addresses the requirement of § 48D(d)(3)(A)(i) of the Code that a new therapy either treats areas of unmet medical need, or prevents, detects, or treats chronic or acute diseases or conditions. For example, unmet medical needs would include novel influenza vaccine technologies, broad spectrum anti-viral medications, novel antibiotics, and platform vaccine technologies. In addition to new therapies that treat diseases and conditions, such products that detect or prevent diseases and conditions are also covered by this provision. Question 7 addresses the requirement of § 48D(d)(3)(A)(ii) of the Code, which covers projects that will reduce long-term health care costs in the United States. The narrative accompanying any Yes response should explain how the project is likely to reduce health care costs, including a description of how the project will lead to actual cost reductions, not just substituting one cost for another and the basis of this determination. The narrative should provide a reasonable estimate of savings and demonstrate a reasonable potential to achieve these savings. Question 8 addresses the requirement of § 48D(d)(3)(A)(iii) of the Code, which covers projects that will significantly advance the goal of curing cancer within the next 30 years. If HHS determines that the applicant satisfies the requirements to which questions 5 through 8 are addressed, regarding the specific statutory selection criteria, HHS will proceed to review the responses to questions 9-11 and evaluate whether the information provided supports a determination that there is a reasonable potential that the project will achieve one or more of the statutory goals. HHS will make this determination based on an analysis of the scientific rationale for the project (question 9), the current stage of development of the project (question 10), and the evidence that the applicant has the capacity to bring the project to fruition (question 11). HHS will notify the Service of the results of the HHS evaluation as to whether the project is a qualifying therapeutic discovery project and shows a reasonable potential to achieve one or more of the statutory goals. Certification Only those qualifying therapeutic development projects that have both (a) a reasonable potential to achieve one or more of the statutory goals set forth in section 48D(d)(3)(A) as determined by HHS and (b) the greatest potential to (i) create and sustain (directly or indirectly) high quality, high-paying jobs in the United States, and (ii) advance United States competitiveness in the fields of life, biological, and medical sciences as determined by the Service will receive a certification for all or a portion of their qualified investment. The Service will certify an amount of qualified investment made by an eligible taxpayer for qualifying therapeutic development projects in accordance with the provisions put forth in this document, obtained from Internal Revenue Code § 48D.