Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations 1271 

PART 993—DRIED PRUNES 

PRODUCED IN CALIFORNIA 

[AMENDED] 

■ Accordingly, the interim final rule 

amending 7 CFR part 993 which was 

published at 74 FR 46310 on September 

9, 2009, is adopted as a final rule, 

without change. 

Dated: January 5, 2010. 

Rayne Pegg, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2010–163 Filed 1–8–10; 8:45 am] 

BILLING CODE 3410–02–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 416 

[Docket No. SSA 2008–0034] 

RIN 0960–AG66 

Technical Revisions to the 

Supplemental Security Income (SSI) 

Regulations on Income and Resources 

AGENCY: Social Security Administration. 

ACTION: Final rules. 

SUMMARY: We are amending our 

Supplemental Security Income (SSI) 

regulations by making technical 

revisions to our rules on income and 

resources. Many of these revisions 

reflect legislative changes found in the 

Consolidated Appropriations Act of 

2001 (CAA), the Economic Growth and 

Tax Relief Reconciliation Act of 2001 

(EGTRRA), an amendment to the 

National Flood Insurance Act of 1968 

(NFIA), the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000 (EEOICPA), and 

the Social Security Protection Act of 

2004 (SSPA). We are also amending our 

SSI rules to extend the home exclusion 

to beneficiaries who, because of 

domestic abuse, leave a home that had 

otherwise been an excludable resource. 

Finally, we are updating our 

‘‘conditional-payment’’ rule to eliminate 

the liquid-resource requirement as a 

prerequisite to receiving conditionalbenefit payments. 

DATES: These final rules are effective on 

February 10, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Donna Gonzalez, Social Insurance 

Specialist, Social Security 

Administration, Office of Income 

Security Programs, 252 Altmeyer 

Building, 6401 Security Boulevard, 

Baltimore, MD 21235–6401, (410) 965– 

7961, for information about this notice. 

For information on eligibility or filing 

for benefits, call our national toll-free 

number, 1–800–772–1213 or TTY 

1–800–325–0778, or visit our Internet 

site, Social Security Online, at http:// 

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: 

Electronic Version 

The electronic file of this document is 

available on the date of publication in 

the Federal Register at http:// 

www.gpoaccess.gov/fr/index.html. 

Explanation of Changes 

We are revising and making final the 

rules we proposed in the notice of 

proposed rulemaking (NPRM) published 

in the Federal Register on December 9, 

2008 (73 FR 74663). These conforming 

changes revise our regulations to reflect 

legislation enacted during the past 

several years and to address two policy 

concerns. 

Background 

The primary goal of the SSI program 

is to ensure a minimum level of income 

to people who are aged 65 or older, 

blind, or disabled, and who have 

limited income and resources. The law 

provides that SSI payments can be made 

only to people who have income and 

resources below specified amounts. 

Therefore, income and resources are 

major factors in deciding SSI eligibility 

and the amount of any SSI payments. 

The Changes We Are Making in These 

Final Rules 

We discuss below the changes we are 

making in these final rules. We have 

grouped the changes by the policy areas 

affected. 

Statutory Employees 

Statutory employees are certain 

independent contractors, including 

agent-drivers or commission-drivers, 

certain full-time life insurance 

salespersons, home workers, and 

traveling or city salespersons. Social 

Security Act (Act) at 210(j)(3) (42 U.S.C. 

410(j)(3)). We are revising section 

416.1110(b) to update the definition of 

net earnings from self-employment to 

include the earnings of statutory 

employees, as provided under section 

519 of the CAA, which amended section 

1612(a)(1) of the Act (42 U.S.C. 

1382a(a)(1)). See Public Law 106–554, 

app. A, 519 (Dec. 21, 2000). Previously, 

we treated statutory employees the same 

as employees for SSI eligibility and 

payment-amount purposes and 

considered their wages as earned 

income. After this change to the Act, we 

now treat statutory employees as selfemployed individuals and count only 

their net earnings, deducting business 

expenses before calculating their 

income. 

Exclusion of Child Tax Credit (CTC) 

From Income and Resources 

We exclude from income the payment 

of a refundable CTC pursuant to the 

EGTRRA. Public Law 107–16, section 

203, 115 Stat. 49 (June 7, 2001) 

(referring to Internal Revenue Code 

section 24, 26 U.S.C. 24). This 

exclusion, which was effective for SSI 

purposes for taxable years beginning on 

or after January 1, 2001, is not currently 

in our regulations. We also exclude the 

payment of a refundable CTC from 

resources for the 9 months following the 

month of receipt. Currently the resource 

exclusion is included under section 

416.1236, titled ‘‘Exclusions from 

resources; provided by other statutes.’’ 

This resource exclusion is now 

provided in the Act at 1613(a)(11) (42 

U.S.C. 1382b(a)(11)), as amended by the 

SSPA, Public Law 108–203, 431 (Mar. 2, 

2004). We are making the following 

revisions to conform to these changes: 

• We are adding new paragraph (m) 

under the heading ‘‘V. Other,’’ in the 

appendix to subpart K to exclude from 

income a refundable CTC paid under 

section 24 of the Internal Revenue Code 

of 1986. This appendix section lists 

types of income excluded under the SSI 

program as provided by Federal laws 

other than the Act. 

• We are amending section 416.1235 

to correctly reflect that the exclusion for 

payment of a refundable CTC is now 

provided under the Act. This provision 

previously appeared in our rules at 

section 416.1236(a)(24) within a list of 

exclusions provided by other statutes. 

We are moving this exclusion to section 

416.1235 but we are not making any 

substantive changes to it. Under this 

provision, a CTC payment is excluded 

from resources for SSI purposes during 

the month the payment is received and 

the following month for payments 

received before March 2, 2004, and for 

the 9 months following the month of 

receipt for payments received on or after 

March 2, 2004. We also are changing the 

title of this section to more accurately 

reflect its contents. 

• We are adding new paragraph (v) to 

section 416.1210, which provides a list 

of general resources we do not count 

when determining SSI eligibility. This 

new paragraph excludes from resources 

the payment of a refundable CTC and 

includes a cross-reference to section 

416.1235. 

• We are removing from section 

416.1236(a) former paragraph (24), 

which had excluded from resources the 

payment of a refundable CTC. As 


cprice-sewell on DSK2BSOYB1PROD with RULES
1272 Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations 

described above, we are adding this 

exclusion to section 416.1235. 

Exclusion of Flood Mitigation Payments 

From Income and Resources 

Payments made for flood mitigation 

activities are not counted as income or 

resources when determining SSI 

eligibility and payment amounts. These 

exclusions are pursuant to an 

amendment to the NFIA of 1968. NFIA, 

section 1324, as amended by Public Law 

109–64, section 1 (Jan. 7, 2005). We are 

making the following revisions to 

conform to these changes: 

• We are adding new paragraph (n) 

under the heading ‘‘V. Other,’’ in the 

appendix to subpart K to exclude from 

income payments made for flood 

mitigation activities. 

• We are adding new paragraph (24) 

to section 416.1236(a) to exclude from 

resources payments for flood mitigation 

activities. 

Exclusion of Energy Employee 

Occupational Illness Medical Benefits 

and Compensation Payment From 

Income and Resources 

Medical benefits and compensation 

payments made to energy employees 

because of occupational illnesses are not 

counted as income or resources for 

purposes of determining eligibility to 

receive, or for determining the amount 

of, certain Federal benefits, including 

SSI. These exclusions are provided 

under section 3646 of the Appendix to 

Public Law 106–398, which established 

the EEOICPA in October 2000. Public 

Law 106–398, section 1, app., title 

XXXVI (October 30, 2000) (section 1 

adopting as Appendix H.R. 5408). We 

are making the following revisions to 

conform to these changes: 

• We are adding new paragraph (o) 

under the heading ‘‘V. Other,’’ in the 

appendix to subpart K to exclude from 

income medical benefits and 

compensation payments made under the 

EEOICPA. 

• We are adding new paragraph (25) 

to section 416.1236(a) to exclude from 

resources medical benefits and 

compensation payments made under the 

EEOICPA. 

Home Exclusion to Victims of Domestic 

Abuse 

An SSI applicant’s or beneficiary’s 

home and associated land are excluded 

from resources by section 1613(a)(1) of 

the Act. Regulations provide that the 

home is excluded so long as it serves as 

the principal place of residence, or the 

SSI applicant or beneficiary maintains 

an active intent to return to the 

residence. The home is also not counted 

as a resource, regardless of the intent to 

return, if the SSI applicant or 

beneficiary resides in an institution, and 

a spouse or dependent relative 

continues to maintain residence in the 

home during the period of 

institutionalization. 

Advocacy groups have expressed 

concern regarding the counting of a 

home as a resource in instances where 

a victim of domestic abuse leaves the 

home and resides elsewhere. Currently, 

a victim fleeing from domestic abuse 

may return to a potentially dangerous 

home environment simply to avoid 

losing SSI because of an ownership 

interest in the home. We agree with 

these concerns and are amending our 

rules. We are adding new paragraph (d) 

to section 416.1212 to extend the home 

exclusion to victims of domestic abuse 

who flee an abusive situation, but 

maintain an ownership interest in an 

otherwise excluded home. This 

exclusion continues until the SSI 

applicant or beneficiary establishes a 

new principal place of residence or 

takes other action rendering the home 

no longer excludable. 

Conditional Payments 

An individual who meets all but the 

resource requirements for SSI may have 

little or nothing on which to live if most 

of his or her resources are non-liquid 

and difficult to convert to cash. Section 

416.1240(a) contains an exception to our 

ordinary resource rules, which allows 

us to pay monthly SSI payments in 

certain circumstances when an SSI 

applicant or beneficiary possesses 

excess non-liquid resources. We can 

make ‘‘conditional payments’’ to give an 

SSI applicant or beneficiary some time 

in which to sell excess non-liquid 

resources and convert them to cash. We 

condition these payments on the SSI 

applicant’s or beneficiary’s written 

agreement to sell these non-liquid 

resources within 9 months for real 

property and within 3 months for all 

other non-liquid resources and repay 

the conditional payments with the 

proceeds. 

Under current rules, we will not make 

conditional payments if the SSI 

applicant or beneficiary has countable 

liquid resources in excess of 3 times the 

monthly Federal Benefit Rate (FBR). The 

original purpose of the liquid-resource 

limit was to ensure that an SSI applicant 

or beneficiary truly needed the 

conditional-payment period. If an SSI 

applicant or beneficiary did not have 

liquid resources equal to 3 months 

worth of SSI payments, then we 

assumed that he or she had inadequate 

liquid resources to meet day-to-day 

expenses. However, if this SSI applicant 

or beneficiary had excess non-liquid 

resources, he or she could agree to 

dispose of those excess resources using 

the conditional-payment rule. 

Conversely, if an SSI applicant or 

beneficiary had liquid resources worth 

more than 3 times the FBR, then we 

assumed that he or she had adequate 

resources and did not need conditional 

payments. 

When we established this rule over 30 

years ago, 3 months worth of SSI 

payments was equal to only about 32% 

of the resource limit. Since then, the 

FBR has increased annually, and the 

resource limit has grown slowly or not 

at all. As of January 2009, 3 times the 

monthly FBR is more than the statutory 

limit on total resources and, therefore, 

has become meaningless. Accordingly, 

we are deleting the limitation on liquid 

resources in paragraph (a)(1) that was a 

prerequisite to receiving conditionalbenefit payments to simplify our 

conditional-payments rule. We are also 

adding a technical cross-reference to 

paragraphs (a)(1) and (a)(2) in 

paragraphs (b) and (c) of section 

416.1240, which was not included in 

the NPRM. 

Public Comments 

In the NPRM, we provided the public 

a 60-day period within which to 

comment on our proposed changes. 

That comment period ended on 

February 9, 2009. We received two 

comments, one from an individual and 

another from an organization, both of 

which indicated full agreement with our 

proposed changes. Therefore, we are 

publishing the text of the proposed rules 

substantively unchanged in these final 

rules, except we also have added the 

cross-reference noted above to 

paragraphs (b) and (c) of section 

416.1240. 

Regulatory Procedures 

Executive Order 12866 

The Office of Management and Budget 

(OMB) determined that the proposed 

rules published on December 9, 2008 at 

73 FR 74663, on which we base these 

final rules, met the criteria for a 

significant regulatory action under 

Executive Order 12866. Therefore, those 

proposed rules were subject to OMB 

review. We received no adverse 

comments on the proposed rules and are 

publishing these final rules 

substantively as proposed, with the 

exception noted above to add a crossreference. Thus, OMB has waived 

further review of these rules. 

Regulatory Flexibility Act 

We certify that these final rules will 

not have a significant economic impact 


cprice-sewell on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations 1273 

on a substantial number of small entities 

as they affect individuals only. 

Therefore, a regulatory flexibility 

analysis as provided in the Regulatory 

Flexibility Act, as amended, is not 

required. 

Paperwork Reduction Act 

These final rules impose no reporting 

or recordkeeping requirements subject 

to OMB clearance. 

(Catalog of Federal Domestic Assistance 

Program No. 96.006, Supplemental Security 

Income) 

List of Subjects in 20 CFR Part 416 

Administrative practice and 

procedure; Aged, Blind, Disability 

benefits; Public assistance programs; 

Reporting and recordkeeping 

requirements; Supplemental Security 

Income (SSI). 

Dated: January 5, 2010. 

Michael J. Astrue, 

Commissioner of Social Security. 

■ For the reasons set forth in the 

preamble, we amend subparts K and L 

of part 416 of chapter III of title 20 of 

the Code of Federal Regulations as 

follows: 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart K—[Amended] 

■ 1. The authority citation for subpart K 

of part 416 continues to read as follows: 

Authority: Secs. 702(a)(5), 1602, 1611, 

1612, 1613, 1614(f), 1621, 1631, and 1633 of 

the Social Security Act (42 U.S.C. 902(a)(5), 

1381a, 1382, 1382a, 1382b, 1382c(f), 1382j, 

1383, and 1383b); sec. 211, Pub. L. 93–66, 87 

Stat. 154 (42 U.S.C. 1382 note). 

■ 2. Revise § 416.1110 paragraph (b) to 

read as follows: 

§ 416.1110 What is earned income. 

* * * * * 

(b) Net earnings from selfemployment. Net earnings from selfemployment are your gross income from 

any trade or business that you operate, 

less allowable deductions for that trade 

or business. Net earnings also include 

your share of profit or loss in any 

partnership to which you belong. For 

taxable years beginning before January 

1, 2001, net earnings from selfemployment under the SSI program are 

the same net earnings that we would 

count under the social security 

retirement insurance program and that 

you would report on your Federal 

income tax return. (See § 404.1080 of 

this chapter.) For taxable years 

beginning on or after January 1, 2001, 

net earnings from self-employment 

under the SSI program will also include 

the earnings of statutory employees. In 

addition, for SSI purposes only, we 

consider statutory employees to be selfemployed individuals. Statutory 

employees are agent or commission 

drivers, certain full-time life insurance 

salespersons, home workers, and 

traveling or city salespersons. (See 

§ 404.1008 of this chapter for a more 

detailed description of these types of 

employees). 

* * * * * 

■ 3. Amend the appendix to subpart K 

of part 416 by adding new paragraphs 

(m), (n), and (o) under Part V to read as 

follows: 

Appendix to Subpart K of Part 416— 

List of Types of Income Excluded Under 

the SSI Program as Provided by Federal 

Laws Other Than the Social Security 

Act 

* * * * * 

V. Other 

* * * * * 

(m) Payments of the refundable child tax 

credit made under section 24 of the Internal 

Revenue Code of 1986, pursuant to section 

203 of the Economic Growth and Tax Relief 

Reconciliation Act of 2001, Public Law 107– 

16 (115 Stat. 49, 26 U.S.C. 24 note). 

(n) Assistance provided for flood 

mitigation activities as provided under 

section 1324 of the National Flood Insurance 

Act of 1968, pursuant to section 1 of Public 

Law 109–64 (119 Stat. 1997, 42 U.S.C. 4031). 

(o) Payments made to individuals under 

the Energy Employees Occupational Illness 

Compensation Program Act of 2000, pursuant 

to section 1 [Div. C, Title XXXVI section 

3646] of Public Law 106–398 (114 Stat. 

1654A–510, 42 U.S.C. 7385e). 

Subpart L—[Amended] 

■ 4. The authority citation for subpart L 

of part 416 continues to read as follows: 

Authority: Secs. 702(a)(5), 1602, 1611, 

1612, 1613, 1614(f), 1621, 1631, and 1633 of 

the Social Security Act (42 U.S.C. 902(a)(5), 

1381a, 1382, 1382a, 1382b, 1382c(f), 1382j, 

1383, and 1383b); sec. 211, Pub. L. 93–66, 87 

Stat. 154 (42 U.S.C. 1382 note). 

■ 5. Amend § 416.1210 by: 

■ a. Adding a comma in the 

introductory sentence after ‘‘(and 

spouse, if any)’’; 

■ b. Removing the word ‘‘and’’ from the 

end of paragraph (t); 

■ c. Removing the period at the end of 

paragraph (u) and adding in its place ‘‘; 

and’’; and 

■ d. Adding a new paragraph (v) to read 

as follows: 

§ 416.1210 Exclusions from resources; 

general. 

* * * * * 

(v) Payment of a refundable child tax 

credit, as provided in § 416.1235. 

■ 6. Amend § 416.1212 by: 

■ a. Redesignating paragraphs (d) 

through (g) as (e) through (h) and adding 

a new paragraph (d) to read as set forth 

below; 

■ b. In redesignated paragraph (e)(2)(ii), 

removing the reference to ‘‘paragraph 

(e)’’ and adding in its place a reference 

to ‘‘paragraph (f)’’; 

■ c. In redesignated paragraph (e)(2)(iii), 

removing the reference to ‘‘paragraph 

(f)’’ and adding in its place a reference 

to ‘‘paragraph (g)’’; and 

■ d. In redesignated paragraph (f), 

removing the reference to ‘‘paragraph 

(d)(2)(ii) of this section’’ and adding in 

its place a reference to ‘‘paragraph 

(e)(2)(ii) of this section’’, and removing 

the reference to ‘‘paragraph (f)’’ and 

adding in its place a reference to 

‘‘paragraph (g)’’. 

§ 416.1212 Exclusion of the home. 

* * * * * 

(d) If an individual leaves the 

principal place of residence due to 

domestic abuse. If an individual moves 

out of his or her home without the 

intent to return, but is fleeing the home 

as a victim of domestic abuse, we will 

not count the home as a resource in 

determining the individual’s eligibility 

to receive, or continue to receive, SSI 

payments. In that situation, we will 

consider the home to be the individual’s 

principal place of residence until such 

time as the individual establishes a new 

principal place of residence or 

otherwise takes action rendering the 

home no longer excludable. 

* * * * * 

■ 7. Revise § 416.1235 to read as 

follows: 

§ 416.1235 Exclusion of certain payments 

related to tax credits. 

(a) In determining the resources of an 

individual (and spouse, if any), we 

exclude for the 9 months following the 

month of receipt the following funds 

received on or after March 2, 2004, the 

unspent portion of: 

(1) Any payment of a refundable 

credit pursuant to section 32 of the 

Internal Revenue Code (relating to the 

earned income tax credit); 

(2) Any payment from an employer 

under section 3507 of the Internal 

Revenue Code (relating to advance 

payment of the earned income tax 

credit); or 

(3) Any payment of a refundable 

credit pursuant to section 24 of the 

Internal Revenue Code (relating to the 

child tax credit). 

(b) Any unspent funds described in 

paragraph (a) of this section that are 

retained until the first moment of the 


cprice-sewell on DSK2BSOYB1PROD with RULES
1274 Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations 

tenth month following their receipt are 

countable as resources at that time. 

(c) Exception: For any payments 

described in paragraph (a) of this 

section received before March 2, 2004, 

we will exclude for the month following 

the month of receipt the unspent 

portion of any such payment. 

■ 8. Amend § 416.1236 by revising 

paragraph (a)(24) and adding a new 

paragraph (a)(25) to read as follows: 

§ 416.1236 Exclusions from resources; 

provided by other statutes. 

(a) * * * 

(24) Assistance provided for flood 

mitigation activities under section 1324 

of the National Flood Insurance Act of 

1968, pursuant to section 1 of Public 

Law 109–64 (119 Stat. 1997, 42 U.S.C. 

4031). 

(25) Payments made to individuals 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000, pursuant to 

section 1, app. [Div. C. Title XXXVI 

section 3646] of Public Law 106–398 

(114 Stat. 1654A–510, 42 U.S.C. 7385e). 

* * * * * 

■ 9. Revise § 416.1240 to read as 

follows: 

§ 416.1240 Disposition of Resources. 

(a) Where the resources of an 

individual (and spouse, if any) are 

determined to exceed the limitations 

prescribed in § 416.1205, such 

individual (and spouse, if any) shall not 

be eligible for payment except under the 

conditions provided in this section. 

Payment will be made to an individual 

(and spouse, if any) if the individual 

agrees in writing to: 

(1) Dispose of, at current market 

value, the nonliquid resources (as 

defined in § 416.1201(c)) in excess of 

the limitations prescribed in § 416.1205 

within the time period specified in 

§ 416.1242; and 

(2) Repay any overpayments (as 

defined in § 416.1244) with the 

proceeds of such disposition. 

(b) Payment made for the period 

during which the resources are being 

disposed of will be conditioned upon 

the disposition of those resources as 

prescribed in paragraphs (a)(1) and 

(a)(2) of this section. Any payments so 

made are (at the time of disposition) 

considered overpayments to the extent 

they would not have been paid had the 

disposition occurred at the beginning of 

the period for which such payments 

were made. 

(c) If an individual fails to dispose of 

the resources as prescribed in 

paragraphs (a)(1) and (a)(2) of this 

section, regardless of the efforts he or 

she makes to dispose of them, the 

resources will be counted at their 

current market value and the individual 

will be ineligible due to excess 

resources. We will use the original 

estimate of current market value unless 

the individual submits evidence 

establishing a lower value (e.g., an 

estimate from a disinterested 

knowledgeable source). 

[FR Doc. 2010–241 Filed 1–8–10; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2009–N–0665] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Hyaluronate 

Sodium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Anika 

Therapeutics, Inc. The supplemental 

NADA provides for a revised human 

food safety warning for use of 

hyaluronate sodium injectable solution 

in horses. 

DATES: This rule is effective January 11, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Anika 

Therapeutics, Inc., 236 W. Cummings 

Park, Woburn, MA 01801, filed a 

supplement to NADA 122–578 that 

provides for the veterinary prescription 

use of HYVISC (hyaluronate sodium) 

Sterile Injection in horses. The 

supplemental NADA provides for a 

revised human food safety warning on 

product labeling. The supplemental 

NADA is approved as of December 11, 

2009, and the regulations are amended 

in 21 CFR 522.1145 to reflect the 

approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

FDA has determined under 21 CFR 

25.33 that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.1145 [Amended] 

■ 2. In paragraph (f)(3)(iii) of § 522.1145, 

remove the third sentence and in its 

place add ‘‘Do not use in horses 

intended for human consumption.’’ 

Dated: December 31, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–207 Filed 1–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2009–N–0665] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Florfenicol 

and Flunixin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original new animal drug 

application (NADA) filed by Intervet, 

Inc. The NADA provides for veterinary 

prescription use of a combination 

injectable solution containing 


cprice-sewell on DSK2BSOYB1PROD with RULES