81_FR_45544 81 FR 45409 - Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment

81 FR 45409 - Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 135 (July 14, 2016)

Page Range45409-45409
FR Document2016-16637

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.

Federal Register, Volume 81 Issue 135 (Thursday, July 14, 2016) 
[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Rules and Regulations]
[Page 45409]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Rules and Regulations 45409 That airspace extending upward from 700 Silver Spring, MD 20993–0002, 240– § 14.1 [Amended] feet above the surface within a 7.5-mile 402–7911. radius of De Quincy Industrial Airpark. ■ 2. In § 14.1, remove and reserve SUPPLEMENTARY INFORMATION: In the paragraph (a)(2)(v). * * * * * Federal Register of February 12, 2016 ASW LA E5 Homer, LA [Removed] (81 FR 7445), FDA published a final rule PART 20—PUBLIC INFORMATION * * * * * entitled ‘‘Removal of Review and Reclassification Procedures for ■ 3. The authority citation for part 20 ASW LA E5 Minden, LA [Amended] Biological Products Licensed Prior to continues to read as follows: Minden Airport, LA July 1, 1972’’ (February 2016 final rule). Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 (Lat. 32°38′46″ N., long. 93°17′53″ W.) In the February 2016 final rule, FDA, in U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401– That airspace extending upward from 700 part, removed § 601.25 (21 CFR 601.25), 1403; 42 U.S.C. 241, 242, 242a, 2421, 242n, feet above the surface within a 6.5-mile which prescribed procedures for FDA’s 243, 262, 263, 263b–263n, 264, 265, 300u– radius of Minden Airport. review of biological products licensed 300u–5, 300aa–1. * * * * * before July 1, 1972. § 20.100 [Amended] ASW LA E5 Slidell, LA [Amended] Under § 14.1(a)(2) (21 CFR 14.1(a)(2)), specific provisions are provided for a ■ 4. In § 20.100, remove and reserve Slidell Airport, LA paragraph (c)(22). (Lat. 30°20′47″ N., long. 89°49′15″ W.) matter that is subject to a hearing before an advisory committee. Under Dated: July 8, 2016. That airspace extending upward from 700 feet above the surface within a 6.5-mile § 20.100(c) (21 CFR 20.100(c)), in Leslie Kux, radius of Slidell Airport, and within 4.0 addition to the provisions of 21 CFR Associate Commissioner for Policy. miles each side of the 360° bearing from the part 20, rules on the availability of [FR Doc. 2016–16637 Filed 7–13–16; 8:45 am] airport extending from the 6.5-mile radius to specific categories of FDA records are BILLING CODE 4164–01–P 9.2 miles north of the airport, and within 4.0 established by regulations under miles each side of the 180° bearing from the Chapter I of Title 21 of the Code of airport extending from the 6.5-mile radius to Federal Regulations. Sections 9.0 miles south of the airport. DEPARTMENT OF THE TREASURY 14.1(a)(2)(v) and 20.100(c)(22) include a Issued in Fort Worth, Texas, on June 27, reference to § 601.25. In the February Internal Revenue Service 2016. 2016 final rule, FDA inadvertently did Walter Tweedy, not remove these sections 26 CFR Part 301 (§§ 14.1(a)(2)(v) and 20.100(c)(22)) that Acting Manager, Operations Support Group, [TD 9778] ATO Central Service Center. referenced § 601.25. Accordingly, FDA is removing and reserving [FR Doc. 2016–16383 Filed 7–13–16; 8:45 am] RIN 1545–BM24 §§ 14.1(a)(2)(v) and 20.100(c)(22). BILLING CODE 4910–13–P Publication of this document Participation of a Person Described in constitutes final action under the Section 6103(n) in a Summons Administrative Procedure Act (5 U.S.C. Interview Under Section 7602(a)(2) of DEPARTMENT OF HEALTH AND 553). FDA has determined that notice the Internal Revenue Code HUMAN SERVICES and public comment is unnecessary because the amendments to the AGENCY: Internal Revenue Service (IRS), Food and Drug Administration regulations are nonsubstantive. Treasury. ACTION: Final regulations and removal of 21 CFR Parts 14 and 20 List of Subjects temporary regulations. [Docket No. FDA–2015–N–2103] 21 CFR Part 14 SUMMARY: This document contains final Administrative practice and regulations modifying regulations under Removal of Review and procedure, Advisory committees, Color section 7602(a) of the Internal Revenue Reclassification Procedures for additives, Drugs, Radiation protection. Code relating to administrative Biological Products Licensed Prior to July 1, 1972; Technical Amendment 21 CFR Part 20 summonses. Specifically, these final regulations clarify that persons with AGENCY: Food and Drug Administration, Confidential business information, whom the IRS or the Office of Chief HHS. Courts, Freedom of information, Counsel (Chief Counsel) contracts for Final rule; technical ACTION: Government employees. services described in section 6103(n) amendment. Therefore, under the Federal Food, and its implementing regulations may Drug, and Cosmetic Act, the Public be included as persons designated to SUMMARY: The Food and Drug Health Service Act, and under authority receive summoned books, papers, Administration (FDA or Agency) is delegated to the Commissioner of Food records, or other data and, in the amending the Agency’s regulations by and Drugs, 21 CFR parts 14 and 20 are presence and under the guidance of an removing certain regulations that amended as follows: IRS officer or employee, participate include obsolete references. FDA is fully in the interview of a witness taking this action to improve the PART 14—PUBLIC HEARING BEFORE summoned by the IRS to provide accuracy of the regulations. A PUBLIC ADVISORY COMMITTEE testimony under oath. These regulations DATES: This rule is effective July 14, mstockstill on DSK3G9T082PROD with RULES ■ 1. The authority citation for part 14 may affect taxpayers, a taxpayer’s 2016. officers or employees, and any third continues to read as follows: FOR FURTHER INFORMATION CONTACT: party who is served with a summons, as Authority: 5 U.S.C. App. 2; 15 U.S.C. well as any other person entitled to Jessica T. Walker, Center for Biologics 1451–1461, 21 U.S.C. 41–50, 141–149, 321– Evaluation and Research, Food and 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 notice of a summons. Drug Administration, 10903 New U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; DATES: Effective Date: These regulations Hampshire Ave., Bldg. 71, Rm. 7301, Pub. L. 108–155; Pub. L. 113–54. are effective on July 14, 2016. VerDate Sep<11>2014 15:55 Jul 13, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\14JYR1.SGM 14JYR1


Document Created: 2016-07-14 01:55:18
Document Modified: 2016-07-14 01:55:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective July 14, 2016.
ContactJessica 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.
FR Citation81 FR 45409 
CFR Citation21 CFR 14
21 CFR 20
CFR AssociatedAdministrative Practice and Procedure; Advisory Committees; Color Additives; Drugs; Radiation Protection; Confidential Business Information; Courts; Freedom of Information and Government Employees
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