[Federal Register Volume 59, Number 87 (Friday, May 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10997]


[[Page Unknown]]

[Federal Register: May 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 606 and 660

[Docket No. 92N-0497]

 

Biological Products; Blood Specificity Designators; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
biologics regulations to correct certain omissions from the designators 
for blood specificities and make other minor, technical amendments. 
This action is being taken to clarify and improve the accuracy of the 
regulations.

EFFECTIVE DATE: May 6, 1994.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-635), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 
301-594-3074.

SUPPLEMENTARY INFORMATION: FDA is correcting certain errors that have 
been incorporated into the biologics regulations in parts 606 and 660 
(21 CFR parts 606 and 660). The errors in the regulations are as 
follows:
    1. In the Federal Register of April 19, 1988 (53 FR 12760), FDA 
changed the name of ``Blood Grouping Serum'' to ``Blood Grouping 
Reagent'' to more accurately describe the product's derivation and 
intended use. However, in Secs.  606.65(c) and 606.121(c)(12)(i), 
(c)(12)(ii), and (c)(12)(iii), the name change was inadvertently 
omitted. The agency is correcting these errors.
    2. In the Federal Register of February 11, 1985 (50 FR 5574), FDA 
changed the name of ``Anti-Human Serum'' to ``Anti-Human Globulin'' to 
reflect that this product may be produced from immunoglobulin-secreting 
cell lines as well as from serum. However, in Sec.  606.65(c), the name 
change was inadvertently omitted. The agency is correcting this error.
    3. Further, in Sec. 660.28(a), the agency is revising the blood 
group antibody designations ``Anti-c,'' and ``Anti-k,'' as ``Anti-c,'' 
and ``Anti-k,''respectively.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure and delayed effective date on this final rule are 
unnecessary because the changes are editorial in nature and 
nonsubstantive (5 U.S.C. 553(b) and (d)).

List of Subjects

21 CFR Part 606

    Blood, Labeling, Laboratories, Reporting and recordkeeping 
requirements.

21 CFR Part 660

    Biologics, Labeling, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR parts 606 and 660 are amended as 
follows:

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
COMPONENTS

    1. The authority citation for 21 CFR part 606 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 505, 510, 520, 701, 704 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 
352, 355, 360, 360j, 371, 374); secs. 215, 351, 353, 361 of the 
Public Health Service Act (42 U.S.C. 216, 262, 263a, 264).


Sec. 606.65  [Amended]

    2. Section 606.65 Supplies and reagents is amended in the table in 
paragraph (c), under the heading ``Reagent or solution'' by removing 
the words ``Anti-human serum'' and adding in their place the words 
``Anti-human globulin'', and by removing the words ``Blood grouping 
serums'' and adding in their place the words ``Blood grouping 
reagents''.


Sec. 606.121  [Amended]

    3. Section 606.121 Container label is amended in paragraphs 
(c)(12)(i), (c)(12)(ii), and (c)(12)(iii) by removing the word 
``Serum'' wherever it appears, and by adding in its place the word 
``Reagent''.

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR 
LABORATORY TESTS

    4. The authority citation for 21 CFR part 660 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. 660.28  [Amended]




    5. Section 660.28 Labeling is amended in the table in paragraph 
(a)(1), under the heading ``Blood grouping reagent'' by removing 
``Anti-c'' and adding in its place ``Anti-c''; in paragraph (a)(4), in 
the second sentence, by removing ``Anti-k'' the second time it appears 
and adding in its place ``Anti-k''.


    Dated: May 2, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-10997 Filed 5-5-94; 8:45 am]
BILLING CODE 4160-01-F