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the regulations is obsolete and in need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
https://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 (https://
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]
=======================================================================
-----------------------------------------------------------------------
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 https://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
