
[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Also, contact information in the regulations is obsolete and in need of 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 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


