Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment, 45409 [2016-16637]

Download as PDF Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Rules and Regulations That airspace extending upward from 700 feet above the surface within a 7.5-mile radius of De Quincy Industrial Airpark. * * * * * ASW LA E5 Homer, LA [Removed] * * * * * ASW LA E5 Minden, LA [Amended] Minden Airport, LA (Lat. 32°38′46″ N., long. 93°17′53″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Minden Airport. * * * * * ASW LA E5 Slidell, LA [Amended] Slidell Airport, LA (Lat. 30°20′47″ N., long. 89°49′15″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Slidell Airport, and within 4.0 miles each side of the 360° bearing from the airport extending from the 6.5-mile radius to 9.2 miles north of the airport, and within 4.0 miles each side of the 180° bearing from the airport extending from the 6.5-mile radius to 9.0 miles south of the airport. Issued in Fort Worth, Texas, on June 27, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2016–16383 Filed 7–13–16; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: In the Federal Register of February 12, 2016 (81 FR 7445), FDA published a final rule entitled ‘‘Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972’’ (February 2016 final rule). In the February 2016 final rule, FDA, in part, removed § 601.25 (21 CFR 601.25), which prescribed procedures for FDA’s review of biological products licensed before July 1, 1972. Under § 14.1(a)(2) (21 CFR 14.1(a)(2)), specific provisions are provided for a matter that is subject to a hearing before an advisory committee. Under § 20.100(c) (21 CFR 20.100(c)), in addition to the provisions of 21 CFR part 20, rules on the availability of specific categories of FDA records are established by regulations under Chapter I of Title 21 of the Code of Federal Regulations. Sections 14.1(a)(2)(v) and 20.100(c)(22) include a reference to § 601.25. In the February 2016 final rule, FDA inadvertently did not remove these sections (§§ 14.1(a)(2)(v) and 20.100(c)(22)) that referenced § 601.25. Accordingly, FDA is removing and reserving §§ 14.1(a)(2)(v) and 20.100(c)(22). Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment is unnecessary because the amendments to the regulations are nonsubstantive. 21 CFR Parts 14 and 20 List of Subjects [Docket No. FDA–2015–N–2103] 21 CFR Part 14 Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA or Agency) is amending the Agency’s regulations by removing certain regulations that include obsolete references. FDA is taking this action to improve the accuracy of the regulations. DATES: This rule is effective July 14, 2016. mstockstill on DSK3G9T082PROD with RULES SUMMARY: FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, VerDate Sep<11>2014 15:55 Jul 13, 2016 Jkt 238001 Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection. 21 CFR Part 20 Confidential business information, Courts, Freedom of information, Government employees. Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 14 and 20 are amended as follows: PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 1. The authority citation for 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; Pub. L. 113–54. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 § 14.1 45409 [Amended] 2. In § 14.1, remove and reserve paragraph (a)(2)(v). ■ PART 20—PUBLIC INFORMATION 3. The authority citation for part 20 continues to read as follows: ■ Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401– 1403; 42 U.S.C. 241, 242, 242a, 2421, 242n, 243, 262, 263, 263b–263n, 264, 265, 300u– 300u–5, 300aa–1. § 20.100 [Amended] 4. In § 20.100, remove and reserve paragraph (c)(22). ■ Dated: July 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16637 Filed 7–13–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9778] RIN 1545–BM24 Participation of a Person Described in Section 6103(n) in a Summons Interview Under Section 7602(a)(2) of the Internal Revenue Code Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. AGENCY: This document contains final regulations modifying regulations under section 7602(a) of the Internal Revenue Code relating to administrative summonses. Specifically, these final regulations clarify that persons with whom the IRS or the Office of Chief Counsel (Chief Counsel) contracts for services described in section 6103(n) and its implementing regulations may be included as persons designated to receive summoned books, papers, records, or other data and, in the presence and under the guidance of an IRS officer or employee, participate fully in the interview of a witness summoned by the IRS to provide testimony under oath. These regulations may affect taxpayers, a taxpayer’s officers or employees, and any third party who is served with a summons, as well as any other person entitled to notice of a summons. DATES: Effective Date: These regulations are effective on July 14, 2016. SUMMARY: E:\FR\FM\14JYR1.SGM 14JYR1

Agencies

[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Rules and Regulations]
[Page 45409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 14 and 20

[Docket No. FDA-2015-N-2103]


Removal of Review and Reclassification Procedures for Biological 
Products Licensed Prior to July 1, 1972; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
the Agency's regulations by removing certain regulations that include 
obsolete references. FDA is taking this action to improve the accuracy 
of the regulations.

DATES: This rule is effective July 14, 2016.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 12, 2016 
(81 FR 7445), FDA published a final rule entitled ``Removal of Review 
and Reclassification Procedures for Biological Products Licensed Prior 
to July 1, 1972'' (February 2016 final rule). In the February 2016 
final rule, FDA, in part, removed Sec.  601.25 (21 CFR 601.25), which 
prescribed procedures for FDA's review of biological products licensed 
before July 1, 1972.
    Under Sec.  14.1(a)(2) (21 CFR 14.1(a)(2)), specific provisions are 
provided for a matter that is subject to a hearing before an advisory 
committee. Under Sec.  20.100(c) (21 CFR 20.100(c)), in addition to the 
provisions of 21 CFR part 20, rules on the availability of specific 
categories of FDA records are established by regulations under Chapter 
I of Title 21 of the Code of Federal Regulations. Sections 
14.1(a)(2)(v) and 20.100(c)(22) include a reference to Sec.  601.25. In 
the February 2016 final rule, FDA inadvertently did not remove these 
sections (Sec. Sec.  14.1(a)(2)(v) and 20.100(c)(22)) that referenced 
Sec.  601.25. Accordingly, FDA is removing and reserving Sec. Sec.  
14.1(a)(2)(v) and 20.100(c)(22).
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comment is unnecessary because the amendments to the 
regulations are nonsubstantive.

List of Subjects

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR parts 14 and 20 are amended as 
follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 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; Pub. 
L. 113-54.


Sec.  14.1  [Amended]

0
2. In Sec.  14.1, remove and reserve paragraph (a)(2)(v).

PART 20--PUBLIC INFORMATION

0
3. The authority citation for part 20 continues to read as follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 2421, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.


Sec.  20.100  [Amended]

0
4. In Sec.  20.100, remove and reserve paragraph (c)(22).

    Dated: July 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16637 Filed 7-13-16; 8:45 am]
 BILLING CODE 4164-01-P

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