[Federal Register Volume 63, Number 65 (Monday, April 6, 1998)]
[Rules and Regulations]
[Page 16685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8971]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 606, 610, 640, and 1270
Foods and Drugs; 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 its
regulations to correct certain errors that have become incorporated
into the biologics regulations. This action is being taken to improve
the accuracy and clarity of the regulations.
EFFECTIVE DATE: April 6, 1998.
FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-2994.
SUPPLEMENTARY INFORMATION: FDA has discovered that certain errors have
become incorporated into the agency's codified regulations on
biologics. FDA is correcting these errors. These corrections are
nonsubstantive.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely correcting
nonsubstantive errors.
Lists of Subjects
21 CFR Part 606
Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 640
Blood, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 1270
Communicable diseases, HIV/AIDS, 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
606, 610, 640, and 1270 are amended as follows:
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371,
374; 42 U.S.C. 216, 262, 263a, 264.
Sec. 606.121 [Amended]
2. Section 606.121 Container label is amended in paragraph
(e)(1)(ii) by removing ``expressd'' and adding in its place
``expressed''.
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
3. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.
Sec. 610.30 [Amended]
4. Section 610.30 Test for Mycoplasma, lines 12, 13, 31, and 33 are
amended by removing the period after the capital ``C'' each time it
occurs.
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
5. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.
Sec. 640.2 [Amended]
6. Section 640.2 General requirements is amended in paragraph
(e)(3) by removing the period after the capital ``C''.
Sec. 640.17 [Amended]
7. Section 640.17 Modifications for specific products is amended by
removing the period after the capital ``C''.
Sec. 640.24 [Amended]
8. Section 640.24 Processing is amended in the first sentence in
paragraph (b) by removing the phrase ``between 20 to 24 deg.C'' and
adding in its place ``between 20 and 24 deg.C''.
Sec. 640.64 [Amended]
9. Section 640.64 Collection of blood for Source Plasma is amended
in paragraph (c)(2) by adding a subscript ``7'' after the first ``O''
in ``Citric acid''.
Sec. 640.69 [Amended]
10. Section 640.69 General requirements is amended in paragraph (b)
by removing the period after the capital ``C''.
Sec. 640.70 [Amended]
11. Section 640.70 Labeling is amended in paragraph (a)(3) by
removing the period after the capital ``C''.
Sec. 640.74 [Amended]
12. Section 640.74 Modification of Source Plasma is amended in
paragraph (b)(2) by removing the period after the capital ``C''.
Sec. 640.101 [Amended]
13. Section 640.101 General requirements is amended in paragraph
(a) by removing the period after the capital ``C''.
Sec. 640.102 [Amended]
14. Section 640.102 Manufacture of Immune Globulin (Human) is
amended in the second and third sentences in paragraph (c) and in the
second sentence in paragraph (e) by removing the period after the
capital ``C'' each time it occurs.
Sec. 640.104 [Amended]
15. Section 640.104 Potency is amended in paragraph (a) by removing
the period after the capital ``C''.
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION
16. The authority citation for 21 CFR part 1270 continues to read
as follows:
Authority: 42 U.S.C. 216, 243, 264, 271.
Sec. 1270.33 [Amended]
17. Section 1270.33 Records, general requirements is amended in
paragraph (b)(1) by removing ``or'' and adding in its place ``and''.
Dated: March 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-8971 Filed 4-3-98; 8:45 am]
BILLING CODE 4160-01-F
