76256 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations 

1Presidential Statement Signing the Social 

Security Act, August 14, 1935. Available at: 

http://www.ssa.gov/history/fdrstmts.html#signing. 

2Section 216(l) of the Act provides for a gradual 

increase in the full retirement age from age 65 to 

age 67. The change first affected those workers born 

in 1938. By 2027, the incremental increases will be 

complete and a full retirement age of 67 will be 

applicable to all workers born in 1960 or later. 

These provisions do not change the age at which 

a worker can take early retirement at a reduced 

benefit amount, which remains age 62. 

may be obtained from NCWM by calling 

402–434–4880, by E-mailing 

nfo@ncwm.net, or on the Internet at 

http://www.nist.gov/owm. 

(b) The following Handbook 44 

requirements are not incorporated by 

reference: 

Scales (2.20) 

S.1.8. Computing Scales 

S.1.8.2. Money-Value Computation 

S.1.8.3. Customer’s Indications 

S.1.8.4. Recorded Representations, Point of 

Sale 

S.2.5.2. Jeweler’s, Prescription, & Class I & II 

Scales 

S.3.3. Scoop Counterbalance 

N.1.3.2. Dairy-Product Test Scales 

N.1.5. Discrimination Test (Not adopted for 

Grain Test Scales only) 

N.1.8. Material Tests 

N.3.1.2. Interim Approval 

N.3.1.3. Enforcement Action For Inaccuracy 

N.4. Coupled-in-Motion Railroad Weighing 

Systems 

N.6. Nominal Capacity of Prescription Scales 

T.1.2. Postal and Parcel Post Scales 

T.2.3. Prescription Scales 

T.2.4. Jewelers’ Scales (all sections) 

T.2.5. Dairy—Product—Test Scales (all 

sections) 

T.N.3.9. Materials Test on Customer— 

Operated Bulk—Weighing Systems for 

Recycled Materials 

UR.1.4. Grain Test Scales: Value of Scale 

Divisions 

UR.3.1. Recommended Minimum Load 

UR.3.1.1. Minimum Load, Grain Dockage 

Automatic Bulk Weighing Systems (2.22) 

N.1.3. Decreasing-Load Test 

J. Dudley Butler, 

Administrator, Grain Inspection, Packers and 

Stockyards Administration. 

[FR Doc. 2010–30712 Filed 12–7–10; 8:45 am] 

BILLING CODE 3410–KD–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Docket No. SSA 2009–0073] 

RIN 0960–AH07 

Amendments to Regulations 

Regarding Withdrawal of Applications 

and Voluntary Suspension of Benefits 

AGENCY: Social Security Administration. 

ACTION: Final rule with request for 

comments. 

SUMMARY: We are modifying our 

regulations to establish a 12-month time 

limit for the withdrawal of old-age 

benefits applications, allow one 

withdrawal per lifetime, and limit the 

voluntary suspension of benefits for 

purposes of receiving delayed 

retirement credits to months for which 

you have not received a payment. We 

are making these changes to revise 

current policies that have the potential 

for misuse. 

DATES: This final rule will be effective 

December 8, 2010. To ensure that your 

comments are considered, we must 

receive them no later than February 7, 

2011. 

ADDRESSES: You may submit comments 

by any one of three methods—Internet, 

fax, or mail. Do not submit the same 

comments multiple times or by more 

than one method. Regardless of which 

method you choose, please state that 

your comments refer to Docket No. 

SSA–2009–0073 so that we may 

associate your comments with the 

correct regulation. 

Caution: You should be careful to 

include in your comments only 

information that you wish to make 

publicly available. We strongly urge you 

not to include in your comments any 

personal information, such as Social 

Security numbers or medical 

information. 

1. Internet: We strongly recommend 

that you submit your comments via the 

Internet. Please visit the Federal 

eRulemaking portal at http:// 

www.regulations.gov. Use the Search 

function to find docket number SSA– 

2009–0073. The system will issue a 

tracking number to confirm your 

submission. You will not be able to 

view your comment immediately 

because we must post each comment 

manually. It may take up to a week for 

your comment to be viewable. 

2. Fax: Fax comments to (410) 966– 

2830. 

3. Mail: Mail your comments to the 

Office of Regulations, Social Security 

Administration, 107 Altmeyer Building, 

6401 Security Boulevard, Baltimore, 

Maryland 21235–6401. 

Comments are available for public 

viewing on the Federal eRulemaking 

portal at http://www.regulations.gov or 

in person, during regular business 

hours, by arranging with the contact 

person identified below. 

FOR FURTHER INFORMATION CONTACT: 

Deidre Bemister, Social Insurance 

Specialist, Social Security 

Administration, Office of Income 

Security Programs, Office of 

Applications and Electronic Services 

Support Policy, 2500 Operations 

Building, 6401 Security Boulevard, 

Baltimore, Maryland 21235, 410–966– 

6223. For information on eligibility or 

filing for benefits, call our national tollfree 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. 

Background 

In 1935, Congress passed the Social 

Security Act (Act), which established 

and funded the Social Security program. 

In his Presidential signing statement, 

President Franklin D. Roosevelt 

affirmed that the lawmakers intended 

the Act to ‘‘give some measure of 

protection to the average citizen and to 

his family against the loss of a job and 

against poverty-ridden old age.’’ 1 Due to 

concerns about the solvency of the 

Social Security program, in 1977 

Congress passed amendments to the Act 

designed to restore the long-term 

balance of the program. Among the 

changes enacted was a delayed 

retirement credit (DRC) that increased 

benefits for those who delay retirement 

past full retirement age (FRA).2

Workers choose when to apply for 

old-age benefits. Workers who apply for 

old-age benefits at FRA will receive full 

benefit rates. Workers may also choose 

to apply before or after FRA. Workers 

who apply between age 62 and FRA will 

receive benefit amounts reduced by a 

certain percentage for each month they 

collect benefits before FRA. Workers 

who apply between FRA and age 70 will 

receive amounts increased by a certain 

percentage for each month they forego 

benefit payments after FRA. Workers 

who live to their average life 

expectancies will receive about the 

same amount in lifetime benefits, 

regardless if they began receiving 

benefits at age 62, FRA, age 70, or any 

age in between. 

Benefit Application Withdrawal 

Workers occasionally reconsider their 

having applied for old-age benefits. 

Continued work is a common reason for 

such reconsideration. The income from 

continued work may bring workers 

earnings over the annual earnings limit 

and require us to withhold benefits. 

Although the Act does not include a 

specific provision concerning 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations 76257 

3 Janet Novack, Trade in Your Social Security 

Check,’’ Forbes, 7 February 2008. Available at: 

http://www.forbes.com/2008/02/07/retirement-rothtaxes-pf-guru-in_jn_0207retirement_inl.html. 

4Munnell, Alicia H., Alex Golub-Sass, and Nadia 

Karamcheva, Strange but True: Free Loan From 

Social Security, Trustees of Boston College, Center 

for Retirement Research. March 2009, Number 9–6. 

Available at: http://crr.bc.edu/images/stories/Briefs/ 

ib_9-6.pdf. 

5 Id. 

withdrawal of an application, we have 

a longstanding policy that allows 

workers to withdraw benefit 

applications. 

Our current regulations permit living 

applicants or beneficiaries to withdraw 

benefit applications for any reason. 

Applicants or beneficiaries need simply 

submit written requests for withdrawal, 

and beneficiaries must repay benefits 

received. Our program experience has 

shown that most workers withdraw 

their applications within one year of 

application. 

Recent media articles have promoted 

the use of our application withdrawal 

process as a means for retired 

beneficiaries to increase their benefits or 

acquire an ‘‘interest-free loan.’’ 3 Our 

current policy permits retirement 

beneficiaries to apply for old-age 

benefits prior to FRA, begin receiving 

reduced benefits, withdraw their 

applications, repay benefits, and 

reapply for full or increased benefits 

later. Under this policy, the payment of 

monthly benefits ceases until the 

beneficiary reapplies, at which time the 

beneficiary receives a higher monthly 

benefit amount than before. 

Reacting to this media attention, the 

Center for Retirement Research at 

Boston College published an article 

titled, Strange but True: Free Loan from 

Social Security that discussed this 

‘‘unconventional claiming strateg[y].’’ 4

The authors very astutely observed that 

our current withdrawal policy has the 

potential to ‘‘pay higher lifetime benefits 

to some individuals and increase system 

costs.’’ 5

This ‘‘free loan’’ is not free. It denies 

the Trust Fund and the Federal 

Government the use of these monies and 

the potential returns on the use of those 

funds. Moreover, the processing of 

withdrawal applications uses resources 

that we could use to serve others. Our 

Nation faces significant challenges 

resulting from the potential number of 

future retirees. Current market and 

economic conditions have exacerbated 

these challenges. 

Additionally, our current withdrawal 

policy has the potential to benefit those 

with the least need. Because a worker 

must repay previously awarded benefits 

in one lump sum, without interest, it is 

unlikely that the average retired 

beneficiary is in a position to reverse 

this earlier decision. Those who have 

the means to take advantage of our 

current policy do so at the expense of 

the Trust Fund. 

Our field offices have noticed an 

increase in the number of application 

withdrawals. We anticipate that the 

number of withdrawals will continue to 

rise if this policy is not changed. The 

current economic climate may lead 

many current retirees to return to work 

in order to obtain a higher future 

benefit. Current retirees with the means 

to repay benefits received could decide 

to do so in order to start collecting 

higher benefits immediately. 

Benefit Suspension 

We currently allow beneficiaries to 

suspend past, current, and future oldage benefit payments. Beneficiaries who 

suspend past payments must repay 

benefits received during the period of 

suspension. This policy also has the 

potential for misuse. Our current policy 

allows workers to apply for old-age 

benefits prior to FRA, begin receiving 

reduced benefits, suspend the benefits 

retroactively, repay benefits, and earn 

DRCs for the period of suspension. 

Workers earn DRCs for each month 

retirement is delayed past FRA up to age 

70. As a result, workers who 

retroactively suspend old-age benefits to 

earn DRCs receive a higher monthly 

benefit amount. Because beneficiaries 

could use retroactive voluntary 

suspension as a vehicle to repay benefits 

and then reapply for higher benefits at 

a later age, we are revising this policy. 

Regulatory Changes 

We are under a clear congressional 

mandate to protect the Trust Funds. It 

is crucial that we change our current 

policies that have the effect of allowing 

beneficiaries to withdraw applications 

or suspend benefits and use benefits 

from the Trust Funds as something akin 

to an interest-free loan. At the same 

time, we also need to ensure that 

beneficiaries who experience an 

unforeseen change of circumstances and 

who may need to withdraw an 

application or suspend benefits are able 

to do so. Establishing limitations on the 

number and scope of application 

withdrawals and on the period for 

which you can voluntarily suspend your 

benefits for purposes of receiving 

delayed retirement credits will help 

prevent abuse and maintain flexibility 

for beneficiaries. 

In our experience, we have not found 

that survivor and disability beneficiaries 

withdraw their applications and repay 

the benefits they have received. 

Applications for old-age benefits are 

most prone to manipulation for personal 

financial gain by our current policies. 

For these reasons, these changes will be 

limited solely to applications for old-age 

benefits. 

We are modifying section 404.640 to 

limit the withdrawal of old-age 

applications. Under this final rule, 

application withdrawals will be limited 

to one withdrawal per lifetime. The 

withdrawal must occur within 12 

months of the first month of 

entitlement. This 12-month limitation 

will allow flexibility for beneficiaries 

who experience an unexpected change 

in circumstances during that time. In 

addition, limiting the period for 

application withdrawals to within 12 

months of the first month of entitlement 

will minimize the likelihood of abuse 

and the potential harm to the Trust 

Funds. 

We decided to limit the withdrawal of 

old-age benefits to 12 months. We chose 

12 months as an appropriate period 

because it balances giving claimant’s 

flexibility in reconsidering their 

claiming benefit decisions with 

eliminating the ‘‘interest-free loan’’ 

loophole. First, a longer period would 

not appreciably increase the universe of 

claimants who reconsider their claiming 

decisions, because our data show that in 

recent years 85–90 percent of applicants 

who withdrew their applications did so 

in the first twelve months. 

Second, the 12-month limitation 

period is a financial disincentive—there 

is little to be gained by investing 

benefits for only 12 months. Finally, for 

those cases where claimants request 

withdrawal after 12 months, we have 

other ways to address their concerns if 

they wish to change their date of 

entitlement to benefits. For example, we 

can revise a month of election 

determination using existing policies: 

• Evaluating conditional month of 

election determinations—if individuals 

who are subject to the annual earnings 

test are due no payment for the year of 

entitlement, they might believe that they 

need to withdraw their application and 

re-file. However, withdrawing the 

application is unnecessary because we 

may reopen and revise the month of 

election. Because these claimants have 

earnings above the annual earnings 

limit, we consider their month of 

election as ‘‘conditional’’ and would 

automatically revise it to a later date 

based on the annual earnings report; 

• Adjusting benefits to consider the 

effect of work and earnings on benefit 

amounts—if individuals decide to 

return to work, it is unnecessary for 

them to withdraw their application. 

Beneficiaries will receive credit for all 

months in which they do not receive a 


jlentini on DSKJ8SOYB1PROD with RULES
76258 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations 

6 42 U.S.C. 402(w)(2)(B)(ii). 

7 Id. 

8 5 U.S.C. 553(b)(B). 

9 5 U.S.C. 553(d)(3). 

full monthly benefit. When individuals 

reach full retirement age, SSA will 

increase their monthly benefits under a 

process called the adjustment of the 

reduction factor. This process removes 

from the calculation of the ongoing 

benefit at full retirement age, the 

actuarial reduction associated with each 

month for which beneficiaries do not 

receive a full monthly benefit; and, 

• Reopening determinations under 

our rules of administrative finality— 

SSA might discover that duplicate 

postings result in an incorrect payment 

amount, causing a claimant to elect 

retirement benefits instead of widow’s 

benefits. The claimant does not need to 

withdraw the retirement application. 

Instead, we can use our rules of 

administrative finality to reopen the 

prior entitlement decision. 

The 12-month limitations period 

should have no effect on beneficiaries 

who wish to change their month of 

election because of a change in their 

circumstances or because of an error in 

the calculation of their benefits. It 

would, however, effectively eliminate 

‘‘interest-free loans.’’ 

We are also modifying section 

404.313 to limit the voluntary 

suspension of benefits. Under these 

final rules, if we have determined that 

you are entitled to benefits, you may 

voluntarily suspend benefits for any 

month beginning the month after the 

month in which you request that we 

voluntarily suspend your benefits. If 

you apply for benefits, and we have not 

made a determination that you are 

entitled to benefits, you may voluntarily 

suspend benefits for any month for 

which you have not received a payment. 

Under the Act, if the beneficiary is 

entitled to retirement benefits, delayed 

retirement credits may be available if 

the beneficiary ‘‘did not receive benefits 

pursuant to a request by such individual 

that benefits not be paid.’’ 6 In these 

rules, we are interpreting the statutory 

phrase ‘‘did not receive benefits 

pursuant to a request by such individual 

that benefits not be paid’’ to mean that 

the beneficiary may voluntarily suspend 

benefits for purposes of the DRC only on 

a prospective basis. 

Applicants for whom we have not 

made an initial determination may 

voluntarily suspend benefits for 

purposes of the DRC, for any months.7

We recognize that this is a change from 

our current policy. However, because 

the statute refers to benefits that the 

‘‘individual did not receive,’’ rather than 

‘‘received and repaid,’’ we believe that 

the policy we are adopting in these rules 

is consistent with the language of the 

statute and congressional intent. 

The following illustrates the change 

in policy: 

1. Example—Beneficiary currently 

receiving benefits: 

A beneficiary is currently receiving 

old-age benefits and requests to 

voluntarily suspend retroactive, current, 

and future benefits and repay all 

benefits received during the retroactive 

period. 

The beneficiary can suspend benefits 

beginning with the month after the 

month in which the beneficiary requests 

that we voluntarily suspend benefits, 

provided the beneficiary has not 

received a monthly benefit amount for 

those months. The beneficiary may not 

suspend retroactive monthly benefits for 

which we have made a determination or 

suspend retroactive monthly benefits 

that we have already paid. 

2. Example—Applicant filing a new 

application: 

An applicant files for old-age benefits 

one or more months after the month the 

applicant attains FRA. The applicant 

could potentially be due retroactive 

benefits. We have not yet made an 

initial determination about monthly 

benefits or entitlement. In order to earn 

DRCs, the applicant voluntarily requests 

to suspend retroactive, current, and 

future benefits. 

The applicant can suspend past, 

current, and future benefits for months 

to which the applicant is entitled 

because we have not made any monthly 

benefit determinations or payments. 

We believe these changes will not 

penalize applicants who require the 

suspension of unpaid benefits for 

reasons not related to misuse. 

When will we start to use these rules? 

We will start to use these rules on the 

date shown under DATES earlier in this 

preamble. However, we are also inviting 

public comments on the changes made 

by these rules. We will consider any 

relevant comments we receive. We plan 

to publish another final rule document 

to respond to any such comments we 

receive and to make any changes to the 

rules as appropriate based on the 

comments. 

Regulatory Procedures 

We follow the Administrative 

Procedure Act (APA) rulemaking 

procedures specified in 5 U.S.C. 553 

when we develop regulations. Section 

702(a)(5) of the Social Security Act, 42 

U.S.C. 902(a)(5). Generally, the APA 

requires that an agency provide prior 

notice and opportunity for public 

comment before issuing a final rule. The 

APA provides exceptions to its notice 

and public comment procedures when 

an agency finds good cause for 

dispensing with such procedures 

because they are impracticable, 

unnecessary, or contrary to the public 

interest.8

We find that good cause exists for 

proceeding without prior public notice 

and comment in this instance. This final 

rule addresses our policies on benefit 

application withdrawal and retroactive 

benefit suspension that beneficiaries 

could take advantage of to obtain 

increased benefits. Because these 

policies have the potential for abuse, 

any delay in their modification through 

the revision of our regulations could 

result in the harm that we are trying to 

prevent. Providing prior public notice 

may act as a catalyst for more applicants 

and beneficiaries to request withdrawal 

of their applications. Accordingly, we 

find that prior public comment would 

be contrary to the public interest. 

However, we are inviting public 

comment on the final rule and will 

consider any substantive comments we 

receive within 60 days of the 

publication of this final rule. 

In addition, for the reasons cited 

above, we also find good cause for 

dispensing with the 30-day delay in the 

effective date of this final rule.9 We find 

that it is contrary to the public interest 

to delay the effective date of our rule 

changes because any delay in their 

modification could result in the harm 

that we are trying to prevent. 

Accordingly, we are making this final 

rule effective upon publication. 

Executive Order 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the criteria for a significant regulatory 

action under Executive Order 12866 and 

were subject to OMB review. 

Regulatory Flexibility Act 

We certify that this final rule will not 

have a significant economic impact on 

a substantial number of small entities as 

it affects individuals only. Accordingly, 

a regulatory flexibility analysis is not 

required under the Regulatory 

Flexibility Act, as amended. 

Paperwork Reduction Act 

This final rule does not create any 

new or affect any existing collections 

and does not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations 76259 

(Catalog of Federal Domestic Assistance 

Program No. 96.002 Social Security— 

Retirement Insurance.) 

List of Subjects in 20 CFR Part 404 

Aged, Old-age, Survivors and 

disability insurance; Social Security. 

Michael J. Astrue, 

Commissioner of Social Security. 

■ For the reasons set out in the 

preamble, we are amending 20 CFR 

chapter III, part 404, subparts D and G 

as follows: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950–) 

Subpart D—Old-Age, Disability, 

Dependents’ and Survivors’ Insurance 

Benefits; Period of Disability 

■ 1. The authority citation for subpart D 

of part 404 continues to read as follows: 

Authority: Secs. 202, 203(a) and (b), 

205(a), 216, 223, 225, 228(a)–(e), and 

702(a)(5) of the Social Security Act (42 U.S.C. 

402, 403(a) and (b), 405(a), 416, 423, 425, 

428(a)–(e), and 902(a)(5)). 

■ 2. Amend § 404.313(a) to add fifth and 

sixth sentences to the end of the 

paragraph to read as follows: 

§ 404.313 What are delayed retirement 

credits and how do they increase my oldage benefit amount? 

(a) * * * If we have determined that 

you are entitled to benefits, you may 

voluntarily suspend benefits for any 

month beginning with the month after 

the month in which you voluntarily 

request that we suspend your benefits. 

If you apply for benefits, and we have 

not made a determination that you are 

entitled to benefits, you may voluntarily 

have your benefits suspended for any 

month for which you have not received 

a payment. 

* * * * * 

Subpart G—Filing of Applications and 

Other Forms 

■ 3. The authority citation for subpart G 

of part 404 continues to read as follows: 

Authority: Secs. 202(i), (j), (o), (p), and (r), 

205(a), 216(i)(2), 223(b), 228(a), and 702(a)(5) 

of the Social Security Act (42 U.S.C. 402(i), 

(j), (o), (p), and (r), 405(a), 416(i)(2), 423(b), 

428(a), and 902(a)(5)). 

■ 4. Amend § 404.640 to add new 

paragraph (b)(4) to read as follows: 

§ 404.640 Withdrawal of an application. 

* * * * * 

(b) * * * 

(4) Old age benefits. An old age 

benefit application may be withdrawn 

if, in addition to the requirements of 

this section— 

(i) The request for withdrawal is filed 

within 12 months of the first month of 

entitlement; and 

(ii) The claimant has not previously 

withdrawn an application for old age 

benefits. 

* * * * * 

[FR Doc. 2010–30868 Filed 12–7–10; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Tylosin 

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 abbreviated new 

animal drug application (ANADA) filed 

by Huvepharma AD. The ANADA 

provides for use of tylosin tartrate 

soluble powder in drinking water of 

chickens, turkeys, swine, and honey 

bees for the treatment or control of 

various bacterial diseases. 

DATES: This rule is effective December 8, 

2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Huvepharma AD, 33 James Boucher 

Blvd., Sophia 1407, Bulgaria, filed 

ANADA 200–473 that provides for use 

of PHARMASIN (tylosin tartrate) 

Soluble in medicated drinking water for 

chickens, turkeys, swine, and honey 

bees for the treatment or control of 

various bacterial diseases. Huvepharma 

AD’s PHARMASIN Soluble is approved 

as a generic copy of Elanco Animal 

Health’s TYLAN Soluble, approved 

under NADA 13–076. The ANADA is 

approved as of October 1, 2010, and the 

regulations in 21 CFR 520.2640 are 

amended to reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

The Agency 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 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. In § 520.2640, revise paragraphs (a), 

(b), and (d)(3)(ii) to read as follows: 

§ 520.2640 Tylosin. 

(a) Specifications. Each container 

contains tylosin tartrate equivalent to 

100 grams tylosin base. 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter. 

(1) No. 000986 for use as in paragraph 

(d) of this section. 

(2) No. 016592 for use as in 

paragraphs (d)(1), (d)(2), (d)(3)(i), 

(d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this 

section. 

* * * * * 

(d) * * * 

(3) * * * 

(ii) Indications for use—(A) For the 

treatment and control of swine 

dysentery associated with Brachyspira 

hyodysenteriae and for the control of 

porcine proliferative enteropathies (PPE, 

ileitis) associated with Lawsonia 

intracellularis. 

(B) For the treatment and control of 

swine dysentery associated with B. 

hyodysenteriae. 

* * * * * 


jlentini on DSKJ8SOYB1PROD with RULES