Biologics; Technical Amendment

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