Public Hearing Before a Public Advisory Committee; Technical Amendments, 17086-17087 [2013-06354]

Download as PDF 17086 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures, paragraph 311d. This airspace action is an administrative change to the descriptions of the affected restricted area to update the using agency name. It does not alter the dimensions, altitudes, or times of designation of the airspace; therefore, it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 73 Airspace, Prohibited areas, Restricted areas. Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows: PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. § 73.29 [Amended] 2. Section 73.29 is amended as follows: ■ 1. R–2914A Valparaiso, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ wreier-aviles on DSK5TPTVN1PROD with RULES 2. R–2914B Valparaiso, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 3. R–2915A Eglin AFB, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 4. R–2915B Eglin AFB, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and VerDate Mar<14>2013 15:24 Mar 19, 2013 Jkt 229001 inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 5. R–2915C Eglin AFB, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 6. R–2918 Valparaiso, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 7. R–2919A Valparaiso, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ 8. R–2919B Valparaiso, FL [Amended] By removing the words ‘‘Using agency. U.S. Air Force, Commander, Air Armament Center, Eglin AFB, FL,’’ and inserting the words ‘‘Using agency. U.S. Air Force, Commander, 96th Test Wing, Eglin AFB, FL’’ Issued in Washington, DC, on March 14, 2013. Gary A. Norek, Manager, Airspace Policy and ATC Procedures Group. [FR Doc. 2013–06366 Filed 3–19–13; 8:45 am] BILLING CODE 4910–13–P 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. 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. 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 crossreferences. 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). SUPPLEMENTARY INFORMATION: 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: ACTION: Final rule; technical amendments. PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 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 ■ PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 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. E:\FR\FM\20MRR1.SGM 20MRR1 Federal Register / Vol. 78, No. 54 / Wednesday, March 20, 2013 / Rules and Regulations PART 14 [AMENDED] 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.’’ ■ 3. Amend § 14.1 by revising paragraphs (a) introductory text, (a)(2)(vii), and (f) to read as follows: ■ § 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. ■ 4. Amend § 14.22 by revising paragraphs (b)(6) and (i)(4) to read as follows: § 14.22 Meetings of an advisory committee. wreier-aviles on DSK5TPTVN1PROD with RULES * * * * * (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. ■ 5. Amend § 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: § 14.55 Termination of advisory committees. * * * VerDate Mar<14>2013 * * 15:24 Mar 19, 2013 Jkt 229001 (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 § 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. * * * * * ■ 6. Amend § 14.65 by revising paragraph (a) to read as follows: § 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. * * * * * § 14.120 [Amended] 7. Amend § 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)).’’ ■ § 14.122 [Amended] 8. Amend § 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). ■ § 14.125 [Amended] 9. Amend § 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). ■ PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 § 14.130 17087 [Amended] 10. Amend § 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] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG–2013–0047] RIN 1625–AA08 Special Local Regulation; New River Raft Race, New River; Fort Lauderdale, FL Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: SUMMARY: The Coast Guard is establishing a special local regulation on the New River in Fort Lauderdale, Florida during the Rotary Club of Fort Lauderdale New River Raft Race, on Saturday, March 23, 2013. The special local regulation is necessary to ensure the safety of the participants, participant vessels, and the general public during the event. Persons and vessels, except those participating in the event, are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Miami or a designated representative. DATES: This rule will is effective from 12 p.m. until 1:30 p.m. on March 23, 2013. ADDRESSES: Documents mentioned in this preamble are part of docket USCG– 2013–0047. To view documents mentioned in this preamble as being available in the docket, go to http:// www.regulations.gov, type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Lieutenant Junior Grade Mike H. Wu, Sector Miami Prevention E:\FR\FM\20MRR1.SGM 20MRR1

Agencies

[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.

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

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]
BILLING CODE 4160-01-P