[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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