[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Rules and Regulations]
[Pages 17086-17087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2013-N-0011]


Public Hearing Before a Public Advisory Committee; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations regarding advisory committees to address minor technical 
changes and corrections to statutory citations. This action is 
editorial in nature and is intended to provide accuracy and clarity to 
the Agency's regulations.

DATES: This rule is effective March 20, 2013.

FOR FURTHER INFORMATION CONTACT: Rosanne A. Hurwitz, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5164, Silver Spring, MD, 20993-0002, 301-796-8866, 
Rosanne.Hurwitz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR part 14 to correct 
minor errors and inadvertent omissions in the Code of Federal 
Regulations (CFR), and to delete obsolete cross-references. Minor 
spelling errors were inadvertently published in the CFR when the 
regulations were first issued. In addition, amendments to the Federal 
Food, Drug, and Cosmetic Act and recodification of certain sections of 
the Public Health Service Act resulted in changes to several of the 
referenced statutes.
    FDA is publishing the document as a final rule under the 
Administrative Procedures Act (5 U.S.C. 551, et seq.). FDA has 
determined that good cause exists to dispense with prior notice and 
public comment under 5 U.S.C. 553(b)(B) and 21 CFR 10.40(e) since such 
notice and comment are unnecessary because this amendment to the 
regulations provides only technical changes to correct minor errors and 
inadvertent omissions in the CFR, to update obsolete terms and 
citations, and to delete obsolete information. These changes are 
nonsubstantive and only editorial in nature. In addition, FDA finds 
good cause to provide for this regulation to be effective immediately 
upon publication under 5 U.S.C. 553(d).

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Foods, Medical Devices, Radiation protection, and 
Tobacco Control.

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

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.

[[Page 17087]]

PART 14 [AMENDED]

0
2. Part 14 is amended by removing the words ``the Board of Tea 
Experts'' wherever they appear; by removing the word ``chairman'' 
wherever it appears and adding in its place ``Chairperson''; by 
removing the word ``chairman's'' wherever it appears and adding in its 
place ``Chairperson's''; by removing the phrase ``the act'' and adding 
in its place ``the FD&C Act''; and by removing the word ``executive 
secretary'' wherever it appears and adding in its place ``Designated 
Federal Officer.''

0
3. Amend Sec.  14.1 by revising paragraphs (a) introductory text, 
(a)(2)(vii), and (f) to read as follows:


Sec.  14.1  Scope.

    (a) This part governs the procedures when any of the following 
applies:
* * * * *
    (2) * * *
    (vii) Section 514(b)(5) of the FD&C Act on establishment, 
amendment, or revocation of a device performance standard;
* * * * *
    (f) This part applies to all FDA advisory committees, except to the 
extent that specific statutes require otherwise for a particular 
committee, for example, TEPRSSC and advisory committees established 
under the Medical Device Amendments of 1976.

0
4. Amend Sec.  14.22 by revising paragraphs (b)(6) and (i)(4) to read 
as follows:


Sec.  14.22  Meetings of an advisory committee.

* * * * *
    (b) * * *
    (6) The committee is concerned with matters that functionally or 
historically occur in some other location, e.g., the Science Advisory 
Board of the National Center for Toxicological Research will generally 
hold meetings in the Little Rock, AR, vicinity.
* * * * *
    (i) * * *
    (4) Notes or minutes kept or reports prepared by a committee member 
have no status or effect unless adopted into the official minutes or 
report by the committee.

0
5. Amend Sec.  14.55 by removing paragraph (d); redesignating 
paragraphs (e) and (f) as paragraphs (d) and (e), respectively; and 
revising paragraph (c) and newly redesignated paragraph (d) to read as 
follows:


Sec.  14.55  Termination of advisory committees.

* * * * *
    (c) TEPRSSC is a permanent statutory advisory committee established 
by section 358(f)(1)(A) of the Public Health Service Act, as added by 
the Radiation Control for Health and Safety Act of 1968, transferred to 
the FD&C Act (21 U.S.C. 360kk(f)(1)(A)), and is not subject to 
termination and renewal under paragraph (a) of this section, except 
that a new charter is prepared and filed at the end of each 2-year 
period as provided in Sec.  14.40(c). Also, the statutory medical 
device classification panels established under section 513(b)(1) of the 
FD&C Act (21 U.S.C. 360c(b)(1)) and part 860, and the statutory medical 
device good manufacturing practice advisory committees established 
under section 520(f)(3) of the FD&C Act (21 U.S.C. 360j(f)(3)), are 
specifically exempted from the normal 2-year duration period.
    (d) Color additive advisory committees are required to be 
established under the circumstances specified in sections 721(b)(5)(C) 
and (D) of the FD&C Act (21 U.S.C. 379e(b)(5)(C) and (D)). A color 
additive advisory committee is subject to the termination and renewal 
requirements of the Federal Advisory Committee Act and of this part.
* * * * *

0
6. Amend Sec.  14.65 by revising paragraph (a) to read as follows:


Sec.  14.65  Public inquiries and requests for advisory committee 
records.

    (a) Public inquiries on general committee matters, except requests 
for records, are to be directed to the Committee Management Officer in 
the Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993.
* * * * *


Sec.  14.120  [Amended]

0
7. Amend Sec.  14.120 by removing ``Radiation Control for Health and 
Safety Act of 1968 (42 U.S.C. 263f(f)(1)(A))'' and adding in its place 
``Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360kk(f)(1)(A)).''


Sec.  14.122  [Amended]

0
8. Amend Sec.  14.122 by removing ``42 U.S.C. 263f'' and adding in its 
place ``21 U.S.C. 360kk'' in paragraphs (a)(2) and (b).


Sec.  14.125  [Amended]

0
9. Amend Sec.  14.125 by removing ``42 U.S.C. 263f (f)(1)(A)'' and 
adding in its place ``21 U.S.C. 360kk(f)(1)(A)'' in paragraph (c).


Sec.  14.130  [Amended]

0
10. Amend Sec.  14.130 by removing ``42 U.S.C. 263f (f)(1)(B)'' and 
adding in its place ``21 U.S.C. 360kk(f)(1)(B)'' in paragraph (a).

    Dated: March 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06354 Filed 3-19-13; 8:45 am]
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