Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 16163 

provides manufacturers greater 

flexibility to meet regulatory 

requirements, the Agency certifies that 

the final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The purpose of this final rule is to 

protect consumers from those labeling 

errors that are more likely to cause 

adverse health consequences, while 

eliminating the regulatory burden of 

applying the rule to labeling unlikely to 

reach or adversely affect consumers. 

This rule amends the 1993 final rule by 

limiting the scope to cut labeling for 

immediate container labels, individual 

unit cartons, and multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons. This rule also increases 

flexibility for firms selecting special 

labeling control procedures by adding a 

provision for the use of any automated 

technique, including differentiation by 

size and shape, that physically prevents 

incorrect labeling from being processed 

by labeling and packaging equipment. 

Therefore, this rule is expected to have 

a positive economic impact on drug 

manufacturers that would otherwise be 

subject to the more stringent 

requirements under current regulations. 

V. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VI. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) 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. 

List of Subjects in 21 CFR Part 211 

Drugs, Labeling, Laboratories, 

Packaging and containers, Prescription 

drugs, Reporting and recordkeeping 

requirements, Warehouses. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 211 is 

amended as follows: 

PART 211—CURRENT GOOD 

MANUFACTURING PRACTICE FOR 

FINISHED PHARMACEUTICALS 

■ 1. The authority citation for 21 CFR 

part 211 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 

■ 2. Section 211.122 is amended by 

revising the introductory text of 

paragraph (g) and by adding paragraph 

(g)(4) to read as follows: 

§ 211.122 Materials examination and usage 

criteria. 

* * * * * 

(g) If cut labeling is used for 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons, packaging and labeling 

operations shall include one of the 

following special control procedures: 

* * * * * 

(4) Use of any automated technique, 

including differentiation by labeling 

size and shape, that physically prevents 

incorrect labeling from being processed 

by labeling and packaging equipment. 

* * * * * 

Dated: March 13, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6502 Filed 3–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

28 CFR Parts 35 and 36 

[CRT Docket No. 122; AG Order No. 3326– 

2012] 

RIN 1190–AA68 

Nondiscrimination on the Basis of 

Disability by Public Accommodations 

and in Commercial Facilities; 

Swimming Pools 

AGENCY: Civil Rights Division, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: By this rule, the Department 

of Justice is extending the date for 

compliance with certain requirements 

in the 2010 Americans with Disabilities 

Act (ADA) Standards for Accessible 

Design (2010 Standards) that relate to 

provision of accessible entry and exit for 

swimming pools, wading pools, and 

spas. This final rule, based on a finding 

of good cause, changes the date for 

compliance from March 15, 2012, to 

May 21, 2012 in order to allow 

additional time to address 

misunderstandings regarding 

compliance with these ADA 

requirements. Some pool owners and 

operators believed that taking certain 

steps would always satisfy their 

obligations under the ADA when in fact 

those steps would not necessarily result 

in compliance with the ADA 

regulations. 

DATES: Effective on March 15, 2012, the 

compliance date for 28 CFR 

35.150(b)(1), (b)(2)(ii), and 28 CFR 

36.304(d)(2)(iii) for sections 242 and 

1009 of the 2010 Standards is delayed 

to May 21, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Allison Nichol, Chief, Disability Rights 

Section, Civil Rights Division, U.S. 

Department of Justice, at (202) 307–0663 

(voice or TTY). This is not a toll-free 

number. Information may also be 

obtained from the Department’s toll-free 

ADA Information Line at (800) 514– 

0301 (voice) or (800) 514–0383 (TTY). 

This rule is also available in an 

accessible format on the ADA Home 

Page at http://www.ada.gov. You may 

obtain copies of this rule in large print 

or on computer disk by calling the ADA 

Information Line listed above. 

SUPPLEMENTARY INFORMATION: The 

Department of Justice published its 

revised final regulations implementing 

the Americans with Disabilities Act 

(ADA) for title II (State and local 

government services) and title III (public 

accommodations and commercial 

facilities) on September 15, 2010. See 75 

FR 56163. The revised ADA rules were 

the result of a six-year process to update 

the Department’s regulations. As part of 

this process, the Department sought 

extensive public comment, issuing an 

Advance Notice of Proposed 

Rulemaking (ANPRM) on September 30, 

2004, 69 FR 58768, and two Notices of 

Proposed Rulemaking (NPRM) on June 

17, 2008, 73 FR 34466 (title II), and 73 

FR 34508 (title III). The Department also 

held a public hearing on the NPRMs and 

received over 4,435 written public 

comments. On September 15, 2010, the 

Department published a final rule 

revising the regulations implementing 

titles II and III of the ADA. As part of 

this revision, the Department adopted 

the 2010 ADA Standards for Accessible 


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16164 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 

Design (‘‘2010 Standards’’), which are 

based in large part on the 2004 ADA 

Accessibility Guidelines adopted by the 

United States Access Board in 2004. See 

69 FR 44083 (July 23, 2004). With 

limited exception, the Department’s 

revised regulations went into effect on 

March 15, 2011. 

With a compliance deadline of March 

15, 2012, the 2010 Standards set 

minimum scoping and technical 

requirements for accessible entry and 

exit for new construction and alteration 

of swimming pools, wading pools, and 

spas (collectively, ‘‘pools’’). In addition, 

the title III regulation provides that as of 

March 15, 2012, public 

accommodations’ barrier removal efforts 

must comply with the 2010 Standards to 

the extent readily achievable, including 

with respect to barriers to accessing 

pools. 28 CFR 36.304 (d)(2)(iii). The title 

II regulation provides that the 2010 

Standards apply where public entities 

choose to meet their title II ADA 

program access obligations by making 

structural changes to their pools. 28 CFR 

35.150(b)(1), (b)(2)(ii). 

Regulatory Certifications 

Administrative Procedure Act 

The Department of Justice finds that 

good cause exists for adopting this rule 

as a final rule with an immediate 

effective date because proceeding via 

ordinary Administrative Procedure Act 

process would be impracticable and 

contrary to the public interest. See 5 

U.S.C. 553(b). The Department 

promulgated a Final Rule on September 

15, 2010 (the 2010 Final Rule), adopting 

the 2010 ADA Standards for Accessible 

Design and implementing ADA title II 

requirements for program accessibility 

and the title III requirements for readily 

achievable barrier removal as applied to 

existing swimming programs and 

swimming pools. As the March 15, 

2012, date for compliance approached, 

the Department received a large number 

of inquiries regarding the obligations of 

owners and operators of existing pools 

under the 2010 Final Rule. On January 

31, 2012, the Department of Justice Civil 

Rights Division published a technical 

assistance document entitled ‘‘ADA 

2010 Revised Requirements: Accessible 

Pools—Means of Entry and Exit’’ (the 

‘‘TA Document’’). The Civil Rights 

Division issued the TA document to 

educate public entities and public 

accommodations about their obligations 

under the ADA regulations as revised by 

the 2010 Final Rule. 

Both the inquiries received by the 

Department prior to the TA Document’s 

publication and the pool owners and 

operators’ response to the TA Document 

reveal that there were 

misunderstandings among a substantial 

number of pool owners and operators 

concerning the obligations imposed by 

the ADA as implemented in the 2010 

Final Rule as to their obligations with 

respect to existing pools and their 

options with respect to the provision of 

pool lifts. Some pool owners and 

operators believed that taking certain 

steps would always satisfy their 

obligations when in fact those steps 

would not necessarily result in 

compliance with the ADA regulations. 

Recognizing that pool owners and 

operators face challenges in correcting 

their misunderstandings and 

determining appropriate compliance 

when faced with what is now an 

immediate compliance date, the 

Department determined that it would be 

impracticable and contrary to the public 

interest to retain the existing 

compliance date, and that a brief 60-day 

extension of that date is necessary to 

provide an opportunity for pool owners 

and operators to assess their obligations 

under the Final Rule and determine 

how best to comply. Further, the 

Department is contemporaneously 

issuing a Notice of Proposed 

Rulemaking seeking public comment on 

whether an even longer period of time 

to allow pool owners and operators to 

meet their compliance obligations 

would be appropriate. Accordingly, this 

60-day extension of the compliance date 

is intended to avoid economic effects 

and disruption of the existing status quo 

while enabling public comment and 

meaningful review of those comments 

on the question of whether a longer 

extension of the compliance date is 

warranted. Thus, the government 

concludes that the requisite good cause 

for issuance of this final rule exists, and 

the requirements for notice and 

comment are not applicable to this brief 

extension of the compliance date set 

forth in the 2010 Final Rule. 5 U.S.C. 

553(b). 

Additionally, this rule is effective 

immediately on date of display for 

public inspection in the Federal 

Register. Section 553(d) of the 

Administrative Procedures Act requires 

30-days notice before the effective date 

of a final rule. However, section 

553(d)(1) allows an exception to the 30- 

day notice where a rule relieves a 

restriction. Because this final rule 

relieves a restriction, in the form of an 

existing date for compliance with a 

regulatory requirement, the Department 

invokes section 553(d)(1) to allow an 

immediate effective date. 

Executive Order 12866—Regulatory 

Planning and Review 

This regulation has been drafted and 

reviewed in accordance with Executive 

Order 12866, ‘‘Regulatory Planning and 

Review’’ section 1(b), Principles of 

Regulation. The Department of Justice 

has determined that this rule is a 

‘‘significant regulatory action’’ under 

Executive Order 12866, section 3(f), 

Regulatory Planning and Review, and 

accordingly this rule has been reviewed 

by the Office of Management and 

Budget (OMB). 

Executive Order 12988—Civil Justice 

Reform 

This rule meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988. 

Executive Order 13132—Federalism 

This rule will not have substantial 

direct effects on the States, on the 

relationship between the Federal 

Government and the States, or on 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, in 

accordance with Executive Order 13132, 

it is determined that this rule does not 

have sufficient federalism implications 

to warrant the preparation of a 

Federalism Assessment. 

Regulatory Flexibility Act 

The Attorney General, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. § 605(b)), has reviewed this 

regulation, and by approving it certifies 

that it will not have a significant 

economic impact on a substantial 

number of small entities. This rule 

merely extends for 60 days the 

compliance date of the specified 

provisions of the title II and title III 

ADA rules to avoid economic effects 

and disruption of the existing status quo 

while enabling public comment and 

meaningful review of those comments 

on the question of whether a longer 

extension of the compliance date is 

warranted. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This rule will not 

result in an annual effect on the 

economy of $100,000,000 or more, a 

major increase in costs or prices, or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignVerDate Mar<15>2010 14:59 Mar 19, 2012 Jkt 226001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\20MRR1.SGM 20MRR1

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Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 16165 

based companies in domestic and 

export markets. 

Unfunded Mandates Reform Act of 1995 

Section 4(2) of the Unfunded 

Mandates Reform Act of 1995, 2 U.S.C. 

1503(2), excludes from coverage under 

that Act any proposed or final Federal 

regulation that ‘‘establishes or enforces 

any statutory rights that prohibit 

discrimination on the basis of race, 

color, religion, sex, national origin, age, 

handicap, or disability.’’ Accordingly, 

this rulemaking is not subject to the 

provisions of the Unfunded Mandates 

Reform Act. 

Paperwork Reduction Act of 1995 

This rule does not contain any 

information collection requirements that 

require approval by OMB under the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. 

Dated: March 15, 2012. 

Eric H. Holder, Jr., 

Attorney General. 

[FR Doc. 2012–6748 Filed 3–15–12; 4:45 pm] 

BILLING CODE 4410–13–P 

DEPARTMENT OF THE TREASURY 

Fiscal Service 

31 CFR Parts 321 and 330 

United States Savings Bonds and 

Notes; Payments 

AGENCY: Bureau of the Public Debt, 

Fiscal Service, Treasury. 

ACTION: Final rule. 

SUMMARY: Treasury is changing the 

procedures for financial institutions to 

transmit and receive settlement for 

redeemed definitive (paper) savings 

securities (savings bonds and savings 

notes) from the EZ Clear system to an 

image-based securities process through 

the Federal Reserve. By changing the 

procedures, Treasury will reduce costs 

and provide for a more efficient method 

of processing savings securities through 

the Federal Reserve. Treasury is making 

discretionary the payment of fees to 

paying agents for the processing of 

redeemed definitive savings securities. 

Treasury will have the flexibility to 

adjust paying agent fees and 

significantly reduce program costs. 

DATES: Effective date: April 11, 2012. 

ADDRESSES: You can download this 

Final Rule at the following Internet 

addresses: <http:// 

www.publicdebt.treas.gov>, <http:// 

www.gpo.gov>, or <http:// 

www.regulations.gov>. 

FOR FURTHER INFORMATION CONTACT: D. 

Michael Linder, Director, Division of 

Program Administration, Office of Retail 

Securities, Bureau of the Public Debt, at 

(304) 480–6319 or 

<mike.linder@bpd.treas.gov>. 

Ann Fowler, Attorney-Adviser, Brian 

Metz, Attorney-Adviser, Dean Adams, 

Assistant Chief Counsel, Edward 

Gronseth, Deputy Chief Counsel, Office 

of the Chief Counsel, Bureau of the 

Public Debt, at (304) 480–8692 or 

<dean.adams@bpd.treas.gov>. 

SUPPLEMENTARY INFORMATION: United 

States savings securities are nonmarketable Treasury securities. 

Generally, definitive savings securities 

are redeemed by banks and other 

financial institutions that are authorized 

by Treasury as paying agents to redeem 

eligible savings securities for cash and 

process those securities in accordance 

with Treasury regulations and 

instructions. 

Beginning October 1, 1988, Treasury 

permitted paying agents to transmit and 

receive settlement for redeemed 

definitive savings securities through the 

EZ CLEAR system, under which the 

securities are manually sorted and 

mailed to the appropriate Federal 

Reserve Bank or Branch. Service fees for 

redeemed definitive savings securities 

presented through EZ CLEAR are paid 

to the institution presenting the 

securities to a Federal Reserve Bank. 

Effective April 11, 2012, financial 

institutions will begin to transition the 

submission of redeemed definitive 

savings securities from the EZ CLEAR 

process to an existing image-based 

securities process through the Federal 

Reserve. Use of this existing imagebased securities process will enable 

paying agents to image redeemed 

definitive savings securities in the same 

manner as they do for checks and 

electronically transmit the images to a 

Federal Reserve Processing Site for 

payment. The Federal Reserve will 

provide specific details on the use of the 

image-based securities process while the 

Bureau of the Public Debt will provide 

other detailed instructions to paying 

agents via its Web site at 

www.treasurydirect.gov and other 

established means of communication 

such as FedFlash and FedFocus. The 

new procedures will enable financial 

institutions to eliminate the manual 

sorting of redeemed definitive savings 

securities and mailing them to a Federal 

Reserve Bank for clearing. This will 

simplify and modernize the processing 

of redeemed definitive savings 

securities for paying agents. 

Treasury will be using a more 

streamlined, efficient, and cost-effective 

method for redeeming and processing 

definitive savings securities through a 

Federal Reserve Processing Site to 

which the paying agent is instructed to 

transmit images of redeemed definitive 

savings securities for payment. The 

Federal Reserve Bank of Minneapolis 

will continue to provide fiscal services 

as the designated Treasury Retail 

Securities Site. 

The new procedures eliminate 

exception processing for paying agents 

and greatly reduce their handling costs. 

Accordingly, Treasury is making the 

payment of paying agent fees 

discretionary, which will allow 

Treasury the flexibility to adjust paying 

agent fees and significantly reduce 

Treasury’s program costs. Treasury 

anticipates that most agents will 

continue redeeming definitive savings 

securities as a service to their 

customers. 

Procedural Requirements 

Executive Order 12866. This rule is 

not a significant regulatory action 

pursuant to Executive Order 12866. 

Administrative Procedure Act (APA). 

Because this rule relates to United 

States securities, which are contracts 

between Treasury and the owner of the 

security, this rule falls within the 

contract exception to the APA, 5 U.S.C. 

553(a)(2). As a result, the notice, public 

comment, and delayed effective date 

provisions of the APA are inapplicable 

to this rule. 

Regulatory Flexibility Act. The 

provisions of the Regulatory Flexibility 

Act, 5 U.S.C. 601 et seq., do not apply 

to this rule because, pursuant to 5 

U.S.C. 553(a)(2), it is not required to be 

issued with notice and opportunity for 

public comment. 

Paperwork Reduction Act (PRA). We 

ask for no collections of information in 

this final rule. Therefore, the Paperwork 

Reduction Act, 44 U.S.C. 3501 et seq., 

does not apply. 

Congressional Review Act (CRA). This 

rule is not a major rule pursuant to the 

CRA, 5 U.S.C. 801 et seq., because it is 

a minor amendment that is expected to 

decrease costs for taxpayers; therefore, 

this rule is not expected to lead to any 

of the results listed in 5 U.S.C. 804(2). 

This rule will take effect April 11, 2012, 

after we submit a copy of it to Congress 

and the Comptroller General. 

List of Subjects 

31 CFR Part 321 

Banks and banking, Federal Reserve 

System, Government Securities. 

31 CFR Part 330 

Banks and banking, Federal Reserve 

System, Government Securities. 


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