[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]


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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.

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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