2862 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

manufacture from the formulation 

submitted for approval, but are similar 

enough to be relevant to the agency’s 

determination of bioequivalence. 

■ 6. Amend § 320.21 by revising the 

section heading and paragraph (b)(1) to 

read as follows: 

§ 320.21 Requirements for submission of 

bioavailability and bioequivalence data. 

* * * * * 

(b) * * * 

(1) Evidence demonstrating that the 

drug product that is the subject of the 

abbreviated new drug application is 

bioequivalent to the reference listed 

drug (defined in § 314.3(b) of this 

chapter). A complete study report must 

be submitted for the bioequivalence 

study upon which the applicant relies 

for approval. For all other 

bioequivalence studies conducted on 

the same drug product formulation, the 

applicant must submit either a complete 

or summary report. If a summary report 

of a bioequivalence study is submitted 

and FDA determines that there may be 

bioequivalence issues or concerns with 

the product, FDA may require that the 

applicant submit a complete report of 

the bioequivalence study to FDA; or 

* * * * * 

Dated: January 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–884 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF LABOR 

Wage and Hour Division 

29 CFR Parts 3 and 5 

Protecting the Privacy of Workers: 

Labor Standards Provisions Applicable 

to Contracts Covering Federally 

Financed and Assisted Construction, 

Effectiveness of Information Collection 

Requirements 

AGENCY: Department of Labor, 

Employment Standards Administration, 

Wage and Hour Division. 

ACTION: OMB approval of information 

collection requirements. 

SUMMARY: The Office of Management 

and Budget (OMB) has approved under 

the Paperwork Reduction Act (PRA) 

information collection requirements 

contained in recently revised final 

regulations published by the 

Department of Labor in the Federal 

Register on December 19, 2008. The 

PRA requires this notice to set forth the 

effectiveness of information collection 

requirements contained in a final rule. 

DATES: The amendments to §§ 3.3(b) and 

5.5(a)(3)(ii)(A) and (B)(1) published in 

the Federal Register on December 19, 

2008 (73 FR 77504) have been approved 

by OMB and are effective January 18, 

2009. 

ADDRESSES: Written comments 

regarding the burden-hour estimates or 

other aspects of the information 

collection requirements contained in 29 

CFR parts 3 and 5 may be submitted to: 

Administrator, Wage and Hour Division, 

Room S3502, 200 Constitution Avenue, 

NW., Washington DC 20210. 

FOR FURTHER INFORMATION CONTACT: 

Richard M. Brennan, Director, Division 

of Interpretations and Regulatory 

Analysis, Wage and Hour Division, 

Employment Standards Administration, 

U.S. Department of Labor, Room S– 

3506, 200 Constitution Avenue, NW., 

Washington, DC 20210; telephone: (202) 

693–0051. 

Questions of interpretation and/or 

enforcement of regulations referenced in 

this notice may be directed to the 

nearest Wage and Hour Division (WHD) 

District Office. Locate the nearest office 

by calling the WHD toll-free help line at 

(866) 4US–WAGE ((866) 487–9243) 

between 8 a.m. and 5 p.m. in your local 

time zone, or log onto the WHD’s Web 

site for a nationwide listing of WHD 

District and Area Offices at: http:// 

www.dol.gov/esa/whd/america2.htm. 

This notice is available through the 

printed Federal Register and 

electronically via the http:// 

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

site. 

Copies of this notice may be obtained 

in alternative formats (Large Print, 

Braille, Audio Tape or Disc), upon 

request, by calling (202) 693–0023. 

TTY/TDD callers may dial toll-free (877) 

889–5627 to obtain information or 

request materials in alternative formats. 

SUPPLEMENTARY INFORMATION: On 

December 30, 2008, the Office of 

Management and Budget (OMB) 

approved under the PRA the 

Department of Labor’s information 

collection request for requirements in 29 

CFR 5.5(a)(3)(ii)(A), and 

5.5(a)(3)(ii)(B)(1), as published in the 

Federal Register on December 19, 2008. 

See 73 FR 77504. The current expiration 

date for OMB authorization for this 

information collection is December 31, 

2011. The regulations implement DavisBacon and Related Acts and the 

Copeland Anti-Kickback Act 

requirements, and the regulatory 

changes reduce respondent burden and 

improve privacy protections for laborers 

and mechanics employed on federally 

financed or assisted construction 

contracts by lessening the transmission 

of personal information regarding 

individuals who work on contracts 

subject to Davis-Bacon Act labor 

standards. The preamble to the new 

regulations stated a general effective 

date of January 18, 2009; however, the 

OMB had not yet provided a PRArequired approval for the revised 

information collection requirements 

contained in 29 CFR 3.3, 5.5(a)(3)(ii)(A), 

and 5.5(a)(3)(ii)(B)(1) at the time of their 

publication. 44 U.S.C. 3507(a)(2). An 

agency may not conduct an information 

collection unless it has a currently valid 

OMB approval; therefore, in accordance 

with the PRA, the effective date of the 

information collection requirements in 

the revised regulations was delayed 

until the OMB approved them under the 

PRA. 44 U.S.C. 3506(c)(1)(B)(iii)(V). On 

December 30, 2008, the OMB approved 

the Department’s information collection 

request under Control Number 1215– 

0149; thus, giving effect to the 

requirements, as announced and 

published in the Federal Register on 

December 18, 2008, under the PRA. The 

current expiration date for OMB 

authorization for this information 

collection is December 31, 2011. 

Dated: January 9, 2009. 

Victoria A. Lipnic, 

Assistant Secretary, Employment Standards 

Administration. 

Alexander J. Passantino, 

Acting Administrator, Wage and Hour 

Division. 

[FR Doc. E9–675 Filed 1–15–09; 8:45 am] 

BILLING CODE 4510–27–P 

DEPARTMENT OF LABOR 

Wage and Hour Division 

29 CFR Part 825 

The Family and Medical Leave Act of 

1993, Effectiveness of Information 

Collection Requirements 

AGENCY: Department of Labor, 

Employment Standards Administration, 

Wage and Hour Division. 

ACTION: OMB approval of information 

collection requirements. 

SUMMARY: On December 14, 2008, the 

Office of Management and Budget 

(OMB) approved under the Paperwork 

Reduction Act (PRA) the Department of 

Labor’s information collection request 

for requirements regarding Family and 

Medical Leave Act regulations, as 

published in the Federal Register on 

November 17, 2008. The PRA requires 

this notice to set forth the effectiveness 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2863 

of information collection requirements 

contained in a final rule. 

DATES: The final rule published in the 

Federal Register on November 17, 2008 

(73 FR 67934) has been approved by 

OMB and is effective January 16, 2009. 

The current expiration date for OMB 

authorization for this information 

collection is December 31, 2011. 

ADDRESSES: Written comments 

regarding the burden-hour estimates or 

other aspects of the information 

collection requirements contained in 29 

CFR part 825 may be submitted to: 

Administrator, Wage and Hour Division, 

Room S3502, 200 Constitution Avenue, 

NW., Washington DC 20210. 

FOR FURTHER INFORMATION CONTACT: 

Richard M. Brennan, Director, Division 

of Interpretations and Regulatory 

Analysis, Wage and Hour Division, 

Employment Standards Administration, 

U.S. Department of Labor, Room S– 

3506, 200 Constitution Avenue, NW., 

Washington, DC 20210; telephone: (202) 

693–0051 (this is not a toll-free 

number). 

Questions of interpretation and/or 

enforcement of regulations referenced in 

this notice may be directed to the 

nearest Wage and Hour Division (WHD) 

District Office. Locate the nearest office 

by calling the WHD toll-free help line at 

(866) 4US–WAGE ((866) 487–9243) 

between 8 a.m. and 5 p.m. in your local 

time zone, or log onto the WHD’s Web 

site for a nationwide listing of WHD 

District and Area Offices at: http:// 

www.dol.gov/esa/whd/america2.htm. 

This notice is available through the 

printed Federal Register and 

electronically via the http:// 

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

site. 

Copies of this notice may be obtained 

in alternative formats (Large Print, 

Braille, Audio Tape or Disc), upon 

request, by calling (202) 693–0023 (not 

a toll-free number). TTY/TDD callers 

may dial toll-free (877) 889–5627 to 

obtain information or request materials 

in alternative formats. 

SUPPLEMENTARY INFORMATION: The Office 

of Management and Budget (OMB) has 

approved under the PRA information 

collection requirements contained in 

recently revised final regulations under 

the Family and Medical Leave Act 

published by the Department of Labor in 

the Federal Register on November 17, 

2008. See 73 FR 67934. The preamble to 

the new regulations stated an effective 

date of January 18, 2009; however, the 

OMB had not yet provided a PRArequired approval for the revised 

information collection requirements 

contained in the revised FMLA rules at 

the time of their publication. 44 U.S.C. 

3507(a)(2). An agency may not conduct 

an information collection unless it has 

a currently valid OMB approval; 

therefore, in accordance with the PRA, 

the effective date of the information 

collection requirements in the revised 

regulations was delayed until the OMB 

approved them under the PRA. 44 

U.S.C. 3506(c)(1)(B)(iii)(V). On 

December 14, 2008, the OMB approved 

the Department’s information collection 

request under Control Number 1215– 

0181; thus, giving effect to the 

requirements, as announced and 

published in the Federal Register on 

November 17, 2008, under the PRA. The 

current expiration date for OMB 

authorization for this information 

collection is December 31, 2011. 

Dated: January 9, 2009. 

Victoria A. Lipnic, 

Assistant Secretary, Employment Standards 

Administration. 

Alexander J. Passantino, 

Acting Administrator, Wage and Hour 

Division. 

[FR Doc. E9–674 Filed 1–15–09; 8:45 am] 

BILLING CODE 4510–27–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Valuing and Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: Pension Benefit Guaranty 

Corporation’s regulation on Benefits 

Payable in Terminated Single-Employer 

Plans prescribes interest assumptions 

for valuing and paying certain benefits 

under terminating single-employer 

plans. This final rule amends the benefit 

payments regulation to adopt interest 

assumptions for plans with valuation 

dates in February 2009. As discussed 

below, this final rule does not address 

the interest assumptions under PBGC’s 

regulation on Allocation of Assets in 

Single-Employer Plans. Interest 

assumptions are also published on 

PBGC’s Web site (http://www.pbgc.gov). 

DATES: Effective February 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Manager, Regulatory 

and Policy Division, Legislative and 

Regulatory Department, Pension Benefit 

Guaranty Corporation, 1200 K Street, 

NW., Washington, DC 20005, 202–326– 

4024. (TTY/TDD users may call the 

Federal relay service toll-free at 1–800– 

877–8339 and ask to be connected to 

202–326–4024.) 

SUPPLEMENTARY INFORMATION: PBGC’s 

regulations prescribe actuarial 

assumptions—including interest 

assumptions—for valuing and paying 

plan benefits of terminating singleemployer plans covered by title IV of 

the Employee Retirement Income 

Security Act of 1974. The interest 

assumptions are intended to reflect 

current conditions in the financial and 

annuity markets. 

These interest assumptions are found 

in two PBGC regulations: the regulation 

on Benefits Payable in Terminated 

Single-Employer Plans (29 CFR Part 

4022) and the regulation on Allocation 

of Assets in Single-Employer Plans (29 

CFR Part 4044). Before 2009, PBGC 

updated the assumptions under the two 

regulations each month in a single 

rulemaking document. In a final rule 

published in the Federal Register on 

December 29, 2008 (at 73 FR 79362), 

PBGC announced a change in its 

practice for determining the interest 

assumptions for use under the asset 

allocation regulation. As explained in 

the preamble to that final rule (73 FR 

79362 at 79363), the new practice leads 

to assumptions that remain unchanged 

within a calendar quarter. Accordingly, 

the assumptions published December 

29, 2008, remain in effect for January, 

February, and March 2009, and need not 

be updated for February 2009. Thus this 

final rule document updates the benefit 

payments regulation only. Similarly, 

future updates to the asset allocation 

regulation will be made quarterly rather 

than monthly; between quarterly 

updates of the asset allocation 

regulation, only the benefit payment 

regulation will be updated each month. 

Two sets of interest assumptions are 

prescribed under the benefit payments 

regulation: (1) A set for PBGC to use to 

determine whether a benefit is payable 

as a lump sum and to determine lumpsum amounts to be paid by PBGC (found 

in Appendix B to Part 4022), and (2) a 

set for private-sector pension 

practitioners to refer to if they wish to 

use lump-sum interest rates determined 

using PBGC’s historical methodology 

(found in Appendix C to Part 4022). 

This amendment (1) adds to 

Appendix B to Part 4022 the interest 

assumptions for PBGC to use for its own 

lump-sum payments in plans with 

valuation dates during February 2009, 

and (2) adds to Appendix C to Part 4022 

the interest assumptions for privatesector pension practitioners to refer to if 

they wish to use lump-sum interest rates 

determined using PBGC’s historical 


sroberts on PROD1PC70 with RULES