[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)]
[Rules and Regulations]
[Page 49383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23683]


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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.

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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

     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; 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]

     2. 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. 99-23683 Filed 9-10-99; 8:45 am]
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