Document ID: FDA-2016-N-0011-0001
Agency: fda
Document Type: Rule
Title: Investigational New Drug Applications for Biological Products;  Bioequivalence Regulations; Technical Amendment
Posted Date: 2016-03-28T04:00Z

[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Rules and Regulations]
[Pages 17065-17066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06886]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 312 and 320

[Docket No. FDA-2016-N-0011]

Investigational New Drug Applications for Biological Products; 
Bioequivalence Regulations; 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 
its regulations to update the address for applicants to submit 
investigational new drug applications (INDs) for biological products 
regulated by the Center for Drug Evaluation and Research (CDER). FDA is 
also amending its regulations on the criteria and evidence to assess 
actual and potential bioequivalence problems (bioequivalence 
regulations) to correct a typographical error. FDA is taking this 
action to ensure accuracy and clarity in the Agency's regulations.

DATES: This rule is effective March 28, 2016.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 312.140(a)(2) to 
update the address for applicants to submit INDs for biological 
products regulated by CDER. FDA is amending 21 CFR 320.33(f)(3) of its 
bioequivalence regulations to correct a typographical error by removing 
the phrase ``(first-class metabolism)'' and adding in its place 
``(first-pass metabolism).''
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that

[[Page 17066]]

notice and public comment are unnecessary because this amendment to the 
regulations provides only technical changes to update the address for 
the submission of INDs regulated by CDER and to correct a typographical 
error in the Agency's bioequivalence regulations.

List of Subjects

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 320

    Drugs, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
312 and 320 are amended as follows:

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
1. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 
42 U.S.C. 262.

Sec.  312.140  [Amended]

0
2. Section 312.140 is amended in paragraph (a)(2) by removing ``CDER 
Therapeutic Biological Products'' and adding in its place ``Central'', 
and by removing ``12229 Wilkins Ave., Rockville, MD 20852'' and adding 
in its place ``5901-B Ammendale Rd., Beltsville, MD 20705-1266''.

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

0
3. The authority citation for 21 CFR part 320 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 371.

Sec.  320.33  [Amended]

0
4. Section 320.33 is amended in paragraph (f)(3) by removing ``(first-
class metabolism)'' and adding in its place ``(first-pass 
metabolism)''.

    Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06886 Filed 3-25-16; 8:45 am]
 BILLING CODE 4164-01-P