Organization, functions, and authority delegations: Center for Drug Evaluation and Research; technical amendment,
[Federal Register: September 13, 1999 (Volume 64, Number 176)]
[Rules and Regulations]
[Page 49383]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se99-14]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations of Authority and Organization; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
SUMMARY: The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to correct position titles for delegates in the Center for Drug Evaluation and Research (CDER). This action is necessary to ensure the continued accuracy of the regulations.
EFFECTIVE DATE: September 13, 1999. FOR FURTHER INFORMATION CONTACT:
Leanne Cusumano, Center for Drug Evaluation and Research (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041, or
Donna G. Page, Division of Management Programs (HFA-340), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 4816.
SUPPLEMENTARY INFORMATION: FDA is correcting its regulations in subpart B of part 5 (21 CFR part 5) in two sections that reflect incorrect position titles for delegates within CDER. In the Federal Register of January 17, 1997 (62 FR 2554), FDA amended the regulations for delegations of authority to update titles of CDER delegates and organizational components to reflect organizational restructuring. In two instances, the position titles for the Director and Deputy Director, Office of Generic Drugs (OGD), Office of Pharmaceutical Science (OPS), CDER were inadvertently changed to reflect the Director and Deputy Director, Division of Bioequivalence, OGD, OPS, CDER. Previously, the Director and Deputy Director, OGD, OPS, CDER held those authorities. The Director and Deputy Division Director of Bioequivalence titles should be removed.
List of Subjects in 21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization and functions (Government agencies).
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 5 is amended as follows:
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
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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; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
Sec. 5.22 [Amended]
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Section 5.22 Certification of true copies and use of Departmental seal is amended by removing paragraph (a) (13) (viii). 3. Section 5.31 is amended by revising paragraph (f) (3) to read as follows:
Sec. 5.31 Petitions under part 10.
(f) * * * (3) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, except for those drug products listed in Sec. 314.440(b) of this chapter, are authorized to issue responses to citizen petitions submitted under Sec. 10.30 of this chapter seeking a determination of the suitability of an abbreviated new drug application for a drug product. * * * * * 4. Section 5.93 is amended by revising paragraph (b) to read as follows:
Sec. 5.93 Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications.
* * * * * (b) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER. * * * * *
Dated: September 7, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-23683Filed9-10-99; 8:45 am]
BILLING CODE 4160-01-F
