24138 Federal Register / Vol. 77, No. 78 / Monday, April 23, 2012 / Rules and Regulations 

78020, December 19, 2008 (the current 

regulation), must be sent to the Office of 

Foreign Labor Certification’s (OFLC’s) 

Chicago National Processing Center 

(CNPC) and postmarked no later than 

midnight April 22, 2012, the last day 

before the effective date of the H–2B 

Final Rule. The guidance also provides 

that applications postmarked on or after 

April 23, 2012 will be adjudicated in 

accordance with the requirements 

described in the Final Rule. 

The Department is revising its 

guidance to clarify that the Final Rule 

will not be operative until April 27, 

2012. In accordance with the 

Congressional Review Act, (CRA), 5 

U.S.C. 801, et seq., April 27, 2012 is 60 

days after February 27, 2012, the date on 

which the rule was reported to 

Congress, and the earliest date on which 

the rule can become operative under the 

CRA. See 5 U.S.C. 801(a)(3). While 

section 801(a)(3) does not alter the date 

a rule goes into effect, it prevents an 

agency from enforcing the rule for 60 

days after the rule is reported to 

Congress. 

Accordingly, applications filed under 

the current regulation must be sent to 

the CNPC and postmarked no later than 

midnight April 26, 2012, and 

applications postmarked on or after 

April 27, 2012 will be adjudicated in 

accordance with the requirements 

described in the Final Rule. Any 

application filed under the current 

regulation that is postmarked on or after 

April 27, 2012 will be returned, and the 

employer (and its agent or attorney) 

informed of the need to file a new 

application in accordance with the 

provisions of the new H–2B Final Rule. 

Please note that, as provided in the 

March 20th guidance, employers who 

file H–2B applications with a start date 

of need before October 1, 2013 will not 

be required to obtain the pre-approved 

H–2B registration under 20 CFR 655.15, 

and the Department will continue to 

adjudicate temporary need during the 

processing of applications by reviewing 

the employer’s statement of temporary 

need in Section B of the ETA Form 

9142. Employers with H–2B 

applications postmarked on or after 

April 27, 2012 with a start date of need 

on or after October 1, 2013, must 

comply with all the requirements 

contained in the registration process 

unless the OFLC publishes additional 

guidance in the Federal Register. 

Employers with questions are 

encouraged to submit their questions to 

H-2B.Regulation@dol.gov. The 

Department will provide responses in 

the form of Frequently Asked Questions 

(FAQs) on its Web site. 

Signed in Washington, this 17th day of 

April 2012. 

Jane Oates, 

Assistant Secretary, Employment and 

Training Administration. 

[FR Doc. 2012–9612 Filed 4–20–12; 8:45 am] 

BILLING CODE 4510–FP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2012–N–0002] 

New Animal Drugs for Use in Animal 

Feeds; Tiamulin 

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 

Novartis Animal Health US, Inc. The 

supplemental NADA provides for 

approval of a new concentration of a 

Type A medicated article. 

DATES: This rule is effective April 23, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, email: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Novartis 

Animal Health US, Inc. (Novartis), 3200 

Northline Ave., Suite 300, Greensboro, 

NC 27408, filed a supplement to NADA 

139–472 for DENAGARD (tiamulin 

hydrogen fumarate) Type A medicated 

articles for use of a new product 

formulation in medicated swine feed. 

The supplemental NADA is approved as 

of January 6, 2012, and the regulations 

in 21 CFR 558.4 and 558.600 are 

amended to reflect the approval. 

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 558 

Animal drugs, Animal feeds. 

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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In paragraph (d) of § 558.4, in the 

‘‘Category II’’ table, revise the entries for 

‘‘Tiamulin’’ to read as follows: 

§ 558.4 Requirement of a medicated feed 

mill license. 

* * * * * 

(d) * * * 

CATEGORY II 

Drug 

Assay limits 

percent 1

Type A 

Type B 

maximum 

(100x) 

Assay limits 

percent 1

Type B/C 2

*******

Tiamulin hydrogen fumarate ............................................................................................ 90–115 10 g/lb 90–115/70–130 

*******

1Percent of labeled amount. 

2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a 

Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for 

the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. 

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Federal Register / Vol. 77, No. 78 / Monday, April 23, 2012 / Rules and Regulations 24139 

* * * * * 

■ 3. In § 558.600, revise paragraph (a) 

and the heading of the first column in 

the table in paragraph (e)(1) to read as 

follows: 

§ 558.600 Tiamulin. 

(a) Specifications. Type A article 

containing 363.2 grams of tiamulin 

hydrogen fumarate per pound. 

* * * * * 

(e) * * * 

(1) * * * 

Tiamulin hydrogen fumarate in grams per ton * * * * * * * * * * * * 

*******

* * * * * 

Dated: April 17, 2012. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2012–9708 Filed 4–20–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 570 

[Docket No. FR–5181–F–02] 

RIN 2506–AC22 

State Community Development Block 

Grant Program: Administrative Rule 

Changes 

AGENCY: Office of the Assistant 

Secretary for Community Planning and 

Development, HUD. 

ACTION: Final rule. 

SUMMARY: This final rule makes changes 

to several sections of the regulations for 

the Community Development Block 

Grant (CDBG) program for states (State 

CDBG program). This final rule 

streamlines and updates the regulations 

to reflect statutory changes, clarifies the 

program income requirements, provides 

other clarifications to the State CDBG 

program regulations, and makes a 

conforming change to the regulations 

applicable to the CDBG Entitlement 

program. This final rule also provides 

additional flexibility to states in their 

administration of the program. The final 

rule follows publication of an October 

17, 2008, proposed rule and takes into 

consideration the public comments 

received on the proposed rule. 

DATES: Effective Date: May 23, 2012. 

FOR FURTHER INFORMATION CONTACT: Eva 

C. Fontheim, Community Planning and 

Development Specialist, Office of 

Community Planning and Development, 

Department of Housing and Urban 

Development, 451 Seventh Street SW., 

Room 7182, Washington, DC 20410; 

telephone number 202–708–1322 (this 

number is not toll-free). Individuals 

with speech or hearing impairments 

may access this number through TTY by 

calling the toll-free Federal Relay 

Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 17, 2008, at 73 FR 61757, 

HUD published for public comment a 

proposed rule that would revise HUD’s 

regulations for the State CDBG program 

in 24 CFR part 570, subpart I, in order 

to conform the regulations to current 

statutory requirements concerning 

program income, and to provide 

additional flexibility to states in 

implementing their programs. Title I of 

the Housing and Community 

Development Act of 1974 (42 U.S.C. 

5301–5320) (HCDA) established the 

statutory framework for the CDBG 

program. The primary statutory 

objective of the CDBG program is to 

develop viable communities, by 

providing decent housing and a suitable 

living environment and by expanding 

economic opportunities, principally for 

persons of low- and moderate-income. 

HUD’s regulations implementing the 

CDBG program are located in 24 CFR 

part 570 (entitled ‘‘Community 

Development Block Grants’’). 

Under the State CDBG program, states 

have the opportunity to administer 

CDBG funds for nonentitlement areas. 

Nonentitlement areas include those 

units of general local government that 

do not receive CDBG funds directly. 

States participating in the State CDBG 

program award grants only to units of 

general local government that carry out 

development activities. Annually, each 

state develops funding priorities and 

criteria for selecting projects. HUD’s role 

under the State CDBG program is to 

ensure state compliance with federal 

laws, regulations, and policies. The 

regulations for the State CDBG program 

are codified in subpart I of the part 570 

regulations. 

The proposed regulatory amendments 

described in the October 17, 2008, 

proposed rule were designed to clarify 

how HUD will administer the State 

CDBG program. HUD proposed to 

streamline and update the regulations to 

reflect statutory changes, clarify the 

program income requirements, and 

provide other clarifications to the State 

CDBG regulations that will provide 

states with additional flexibility in their 

administration of the program. 

Interested readers should refer to the 

preamble to the October 17, 2008, 

proposed rule for additional information 

on the proposed regulatory changes to 

the State CDBG program. 

II. This Final Rule; Changes to the 

October 17, 2008, Proposed Rule 

This final rule follows publication of 

the October 17, 2008, proposed rule and 

takes into consideration the public 

comments received on the proposed 

rule. The public comment period on the 

proposed rule closed on December 16, 

2008. HUD received eight responses. 

Commenters included one public 

interest group and seven units of local 

government. Most of the public 

comments pertained to the provisions of 

the proposed rule concerning program 

income requirements. 

After careful consideration of the 

issues raised by the commenters, HUD 

has decided to adopt an amended 

version of the proposed rule. 

Specifically, HUD has made the 

following changes to the October 17, 

2008, proposed rule: 

1. Administrative Expense Cap Time 

Period. The final rule clarifies, at 

§ 570.489(a)(1), that the program income 

included in the calculation determining 

the amount of allowable administrative 

and technical assistance per program 

year is all of the program income 

received in the program year, regardless 

of the fiscal year in which the state grant 

funds were appropriated that generated 

the program income. 

2. Identifies Parties in the Grant 

Agreement for Calculating Program 

Income. Section 570.489(e)(2)(v) of the 

final rule specifies that the grant 

agreement referred to in this section is 

between the state and the unit of general 

local government. 

3. Entitlement Jurisdictions Receive 

Only an Incidental Benefit From State 

CDBG Program Expenditures. The final 

rule, at § 570.486(c), no longer mandates 

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