[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Page 15110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7971]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5, 184, 529, and 610


Food and Drugs; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct certain typographical and other inadvertent 
errors. This action is being taken to clarify and improve the accuracy 
of the regulations.

EFFECTIVE DATE: April 1, 1997.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: FDA has discovered certain nonsubstantive 
errors that have been incorporated into the agency's codified 
regulations. FDA is correcting these errors. The errors in the 
regulations are as follows:
    1. In 21 CFR 5.89(b)(1) ``x-reay'' is corrected to read ``x-ray''.
    2. In 21 CFR 184.1(a) the phrase ``of this chapter of'' in the 
third sentence is corrected to read ``of this chapter or''.
    3. In 21 CFR 529.50(c)(2) ``Klebsiella ssp.'' is corrected to read 
``Klebsiella spp.''.
    4. In 21 CFR 610.53(c), in the table, in the entry for ``Rubella 
Virus Vaccine Live,'' in the third column, under the heading 
``Manufacturer's storage period 0  deg.C or colder (unless otherwise 
stated),'' `` deg.C'' is corrected to read ``do''.
    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.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 184

    Food ingredients.

21 CFR Part 529

    Animal drugs.

21 CFR Part 610

    Biologics, 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 5, 184, 529, and 610 are amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    1. The authority citation for 21 CFR part 5 continues to read as 
follows:
    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 
2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 
242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1); 42 
U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, 
and 12591.


Sec. 5.89  [Amended]

    2. Section 5.89 Notification of defects in, and repair or 
replacement of, electronic products is amended in paragraph (b)(1) by 
removing ``x-reay'' and adding in its place ``x-ray''.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    3. The authority citation for 21 CFR part 184 continues to read as 
follows:
    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


Sec. 184.1  [Amended]

    4. Section 184.1 Substances added directly to human food affirmed 
as generally recognized as safe (GRAS) is amended in the third sentence 
in paragraph (a) by removing the phrase ``of this chapter of'' and 
adding in its place the phrase ``of this chapter or''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    5. The authority citation for 21 CFR part 529 continues to read as 
follows:
    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 529.50  [Amended]

    6. Section 529.50 Amikacin sulfate intrauterine solution is amended 
in paragraph (c)(2) by removing ``Klebsiella ssp.'' and adding in its 
place ``Klebsiella spp.''

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

    7. 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. 610.53  [Amended]

    8. Sec. 610.53 Dating periods for licensed biological products is 
amended in the table in paragraph (c), in the entry for ``Rubella Virus 
Vaccine Live,'' in the third column, under the heading ``Manufacturer's 
storage period 0  deg.C or colder (unless otherwise stated),'' by 
removing `` deg.C'' and adding in its place ``do''.

    Dated: March 25, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-7971 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F