[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]


=======================================================================
-----------------------------------------------------------------------

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