Institutional Review Boards; Correcting Amendments, 16401 [2013-06030]

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Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Rules and Regulations That airspace extending upward from 700 feet above the surface within a 14.8-mile radius of Morrisville-Stowe State Airport. Issued in College Park, Georgia, on March 5, 2013. Barry A. Knight, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. 2013–05910 Filed 3–14–13; 8:45 am] Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 56 is amended as follows: PART 56—INSTITUTIONAL REVIEW BOARDS 1. The authority citation for 21 CFR part 56 continues to read as follows: ■ BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c–360f, 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b–263n. Food and Drug Administration ■ 2. In § 56.106 revise paragraph (d) to read as follows: 21 CFR Part 56 § 56.106 [Docket No. FDA–2013–N–0003] Institutional Review Boards; Correcting Amendments AGENCY: Food and Drug Administration, HHS. Final rule; correcting amendments. srobinson on DSK4SPTVN1PROD with RULES ACTION: SUMMARY: The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency’s regulations. DATES: This final rule is effective March 15, 2013. FOR FURTHER INFORMATION CONTACT: Kathleen Pfaender, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5172, Silver Spring, MD 20993, 301–796–8346. SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR part 56 to correct a minor error in the Code of Federal Regulations (CFR), and to update obsolete information. A minor spelling error was introduced inadvertently in the CFR when the regulations were first published. Also, contact information in the regulations is obsolete and in need of updating. Publication of this document constitutes final action under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to correct minor errors and to update obsolete information, and is nonsubstantive. List of Subjects in 21 CFR Part 56 Human research subjects, Reporting and reporting requirements, and Safety. VerDate Mar<14>2013 16:42 Mar 14, 2013 Jkt 229001 Registration. * * * * * (d) Where can an IRB register? Each IRB may register electronically through http://ohrp.cit.nih.gov/efile. If an IRB lacks the ability to register electronically, it must send its registration information, in writing, to the Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993. * * * * * ■ 3. Section 56.107 is amended in paragraph (a), by revising the 3rd sentence to read as follows: § 56.107 IRB membership. (a) * * * In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. * * * * * * * * Dated: March 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06030 Filed 3–14–13; 8:45 am] BILLING CODE 4160–01–P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Allocation of Assets in SingleEmployer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 16401 SUMMARY: This final rule amends the Pension Benefit Guaranty Corporation’s regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in April 2013 and interest assumptions under the asset allocation regulation for valuation dates in the second quarter of 2013. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC. DATES: Effective April 1, 2013. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion (Klion.Catherine@PBGC.gov), Assistant General Counsel for Regulatory Affairs, 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 on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating singleemployer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC’s Web site (http:// www.pbgc.gov). The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC’s historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same. The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for April 2013 and updates the asset allocation interest E:\FR\FM\15MRR1.SGM 15MRR1

Agencies

[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Rules and Regulations]
[Page 16401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 56

[Docket No. FDA-2013-N-0003]


Institutional Review Boards; Correcting Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations regarding institutional review boards to address a minor 
correction to the regulatory text and to update contact information. 
This action is editorial in nature and is intended to provide accuracy 
and clarity to the Agency's regulations.

DATES: This final rule is effective March 15, 2013.

FOR FURTHER INFORMATION CONTACT:  Kathleen Pfaender, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5172, Silver Spring, MD 20993, 301-796-8346.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR part 56 to correct a 
minor error in the Code of Federal Regulations (CFR), and to update 
obsolete information. A minor spelling error was introduced 
inadvertently in the CFR when the regulations were first published. 
Also, contact information in the regulations is obsolete and in need of 
updating.
    Publication of this document constitutes final action under the 
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that 
notice and public comment are unnecessary because this amendment to the 
regulations provides only technical changes to correct minor errors and 
to update obsolete information, and is nonsubstantive.

List of Subjects in 21 CFR Part 56

    Human research subjects, Reporting and reporting requirements, and 
Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
56 is amended as follows:

PART 56--INSTITUTIONAL REVIEW BOARDS

0
1. The authority citation for 21 CFR part 56 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 
352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 
216, 241, 262, 263b-263n.


0
2. In Sec.  56.106 revise paragraph (d) to read as follows:


Sec.  56.106  Registration.

* * * * *
    (d) Where can an IRB register? Each IRB may register electronically 
through http://ohrp.cit.nih.gov/efile. If an IRB lacks the ability to 
register electronically, it must send its registration information, in 
writing, to the Office of Good Clinical Practice, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993.
* * * * *
0
3. Section 56.107 is amended in paragraph (a), by revising the 3rd 
sentence to read as follows:


Sec.  56.107  IRB membership.

    (a) * * * In addition to possessing the professional competence 
necessary to review the specific research activities, the IRB shall be 
able to ascertain the acceptability of proposed research in terms of 
institutional commitments and regulations, applicable law, and 
standards of professional conduct and practice. * * *
* * * * *

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06030 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P