00-10840. Code of Federal Regulations; Authority Citations

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is revising the authority citations for several of its regulations because one of the citations was repealed by Public Law 104-128, Sec. 2, 110 Stat., 1198. This action is being taken to make the regulations accurate. It does not represent a change in agency policy and does not increase any burdens on the public.

DATES:

This rule is effective May 2, 2000.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION:

On April 9, 1996, Public Law 104-128 was enacted which repealed 21 U.S.C. 41-50. Therefore, FDA is revising the authority citations for 21 CFR parts 10, 13, 14, and 15 to reflect this amendment.

FDA has determined that repeal of 21 U.S.C. 41-50 did not remove needed statutory authority for any current FDA regulation. Because the changes that the agency is making are not substantive and are merely ministerial changes to the Code of Federal Regulations, the Commissioner of Food and Drugs finds that there is good cause not to engage in notice and public comment procedures, which are unnecessary, or to delay the effective date of these amendments.

The agency has determined under 21 CFR 25.30(i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 10, 13, 14, and 15 are amended as follows:

PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES

1. The authority citation for 21 CFR part 10 is revised to read as follows:

Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

PART 13—PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

2. The authority citation for 21 CFR part 13 is revised to read as follows:

Authority: 5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.

PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

3. The authority citation for 21 CFR part 14 is revised to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

PART 15—PUBLIC HEARING BEFORE THE COMMISSIONER

4. The authority citation for 21 CFR part 15 is revised to read as follows:

Authority: 5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.

Dated: April 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.