[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23899]
[Federal Register: September 28, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 600, 610, 630, and 640
[Docket No. 93N-0392]
Biologics; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations by substituting the term ``supplement'' for
``amendment'' when referring to the submission of a change to an
approved establishment license or product license application. This
action is being taken to harmonize the regulations with terminology
used in the Prescription Drug User Fee Act of 1992.
DATES: Effective September 28, 1994; written comments by December 12,
1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-635), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: The Prescription Drug User Fee Act of 1992
(Pub. L. 102-571) (section 735 (21 U.S.C. 379g)) defines the term
``supplement'' as ``a request to the Secretary to approve a change in a
human drug application which has been approved.'' Also in section 735
of the Prescription Drug User Fee Act, a ``human drug application''
includes ``an application for licensure of a biological product under
section 351 of the Public Health Service Act.'' FDA is amending the
biologics regulations by substituting the term ``supplement'' for
``amendment.'' This change is being made to harmonize the regulations
with the terminology used in the Prescription Drug User Fee Act of
1992.
Prior to this announced change in terminology, the term
``amendment'' was used for all changes to both approved and unapproved
license applications and amendments. In general, FDA intends to use the
term ``supplement'' when referring to the submission of a change to an
approved license application, and the term ``amendment'' when referring
to the submission of a change to an unapproved license application or
amendment. This change will not affect pending supplements (amendments)
to establishment or product license applications.
This final rule contains only a minor change that is necessary to
clarify terminology in the regulations. The rule change will not affect
the way a license amendment or supplement to an application should be
submitted to the agency, except in the way it is identified; nor will
the change affect the way a license amendment or supplement will be
reviewed by FDA. Therefore, FDA finds that there is good cause to
dispense with a notice of proposed rulemaking as unnecessary, pursuant
to the Administrative Procedure Act (5 U.S.C. 553) and FDA's
administrative practices and procedures regulations (21 CFR 10.40(e)).
FDA also finds, in accordance with the Administrative Procedure Act,
that there is good cause to make this final rule effective on the date
of publication in the Federal Register. FDA, however, is allowing 75
days for public comment on this final rule, in accordance with 21 CFR
10.40(e)(1).
Interested persons may, on or before December 12, 1994, submit to
the Dockets Management Branch (address above) written comments
regarding this rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday. FDA will consider any
comments submitted to determine if any additional changes to the
regulations are necessary.
List of Subjects
21 CFR Part 600
Biologics, Reporting and recordkeeping requirements.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 630
Biologics, Labeling.
21 CFR Part 640
Blood, Labeling, 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
600, 610, 630, and 640 are amended as follows:
PART 600--BIOLOGICAL PRODUCTS: GENERAL
1. The authority citation for 21 CFR part 600 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 519, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352,
353, 355, 360, 360i, 371, 374); secs. 215, 351, 352, 353, 361 of the
Public Health Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Sec. 600.15 [Amended]
2. Section 600.15 Temperatures during shipment is amended in
paragraph (b) by removing the words ``an amendment'' and by adding in
their place the words ``a supplement''.
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
3. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Sec. 610.9 [Amended]
4. Section 610.9 Equivalent methods and processes is amended in the
first sentence of paragraph (a) by removing the word ``amendment'' and
adding in its place the word ``supplement''.
Sec. 610.11 [Amended]
5. Section 610.11 General safety is amended in the third sentence
of the introductory text by removing the words ``an amendment'' and
adding in their place the words ``a supplement''.
Sec. 610.53 [Amended]
6. Section 610.53 Dating periods for licensed biological products
is amended in paragraph (d) by removing the words ``an amendment'' and
by adding in their place the words ``a supplement''.
PART 630--ADDITIONAL STANDARDS FOR VIRAL VACCINES
7. The authority citation for 21 CFR part 630 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Sec. 630.10 [Amended]
8. Section 630.10 Poliovirus Vaccine Live Oral Trivalent is amended
in paragraph (c)(3) by removing the word ``amendment'' and by adding in
its place the word ``supplement''.
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
9. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
Sec. 640.6 [Amended]
10. Section 640.6 Modifications of Whole Blood is amended in the
introductory text by removing the words ``an amendment'' and adding in
their place the words ``a supplement''.
Sec. 640.21 [Amended]
11. Section 640.21 Suitability of donors is amended in paragraph
(c) by removing the words ``an amendment'' and adding in their place
the words ``a supplement''.
Sec. 640.22 [Amended]
12. Section 640.22 Collection of source material is amended in
paragraph (c) by removing the words ``an amendment'' and adding in
their place the words ``a supplement''.
Sec. 640.64 [Amended]
13. Section 640.64 Collection of blood for Source Plasma is amended
in the second sentence of paragraph (c) by removing the words ``an
amendment'' and adding in their place the words ``a supplement''.
Sec. 640.74 [Amended]
14. Section 640.74 Modification of Source Plasma is amended in
paragraph (a) by removing the words ``an amendment'' and by adding in
their place the words ``a supplement''.
Dated: September 15, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-23899 Filed 9-27-94; 8:45 am]
BILLING CODE 4160-01-F
