[Federal Register Volume 62, Number 12 (Friday, January 17, 1997)]
[Rules and Regulations]
[Pages 2554-2558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Center for Drug 
Evaluation and Research

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for delegations of authority relating to functions 
performed by the Center for Drug Evaluation and Research (CDER). This 
amendment updates the titles of CDER delegates and organizational 
components to reflect the organizational restructuring. This action is 
intended to ensure the accuracy and consistency of the regulations.

EFFECTIVE DATE: January 17, 1997.

FOR FURTHER INFORMATION CONTACT:
    Rixie L. Scott, Center for Drug Evaluation and Research (HFD-54), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-0494, or
    Donna G. Page, Division of Management Systems and Policy (HFA-340), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-4816.

SUPPLEMENTARY INFORMATION: CDER recently underwent a major 
organizational restructuring. The Center level structure was approved 
by the Commissioner of Food and Drugs and published in the Federal 
Register of October 13, 1995 (60 FR 53379). Most of the authorities 
delegated to the center officials are amended in this document to 
reflect new titles and organization placement under the restructuring.
     This document revises the delegations of authority contained in 
part 5 (21 CFR part 5) relating to the functions assigned to CDER.
    Further redelegation of the authorities delegated is not 
authorized. Authority delegated to a position by title may be exercised 
by a person officially designated to serve in such position in an 
acting capacity or on a temporary basis.

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; 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.

    2. Section 5.22 is amended by revising paragraphs (a)(13)(i) 
through (a)(13)(v) and by adding new paragraphs (a)(13)(vi) through 
(a)(13)(viii) to read as follows:


Sec. 5.22  Certification of true copies and use of Department seal.

    (a) *  *  *
    (13)(i) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Director and Deputy Director, Office of Management, CDER.
    (iii) The Director and Deputy Director, Office of Compliance, CDER.
    (iv) The Directors of the Offices of Drug Evaluation I, II, III, 
IV, and V, and the Director and Deputy Director of the Office of 
Epidemiology and Biostatistics, Office of Review Management, CDER.
    (v) The Directors and Deputy Directors of the Offices of Testing 
and Research, Generic Drugs, New Drug Chemistry, and Clinical 
Pharmacology and Biopharmaceutics, Office of Pharmaceutical Science, 
CDER.
    (vi) The Chief, Freedom of Information Staff, Office of Training 
and Communications, CDER.
    (vii) The Directors of the Divisions of Labeling and 
Nonprescription Drug Compliance, Prescription Drug Compliance and 
Surveillance, and Manufacturing and Product Quality, Office of 
Compliance, CDER.
    (viii) The Director and Deputy Director, Division of 
Bioequivalence, Office of Generic Drugs, Office of Pharmaceutical 
Science, CDER.
* * * * *
    3. Section 5.23 is amended by revising paragraph (b) to read as 
follows:


Sec. 5.23  Disclosure of official records.

* * * * *
    (b) The Chief, Product Information Management Branch, Division of 
Database Management, Office of Management, Center for Drug Evaluation 
and Research (CDER), is authorized to sign affidavits regarding the 
presence or absence of records of Registration of Drug Establishments.
* * * * *
    4. Section 5.25 is amended by revising paragraph (a)(6) to read as 
follows:


Sec. 5.25  Research, investigation, and testing programs and health 
information and health promotion programs.

    (a) *  *  *
    (6) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
* * * * *
    5. Section 5.26 is amended by revising paragraph (g) to read as 
follows:


Sec. 5.26  Service fellowships.

* * * * *
    (g) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER), and the Director and Deputy Director, 
Office of Management, CDER.
* * * * *
    6. Section 5.30 is amended by revising paragraphs (a)(2) and (c)(3) 
to read as follows:


Sec. 5.30  Hearings.

    (a) *  *  *
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); the Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER; 
and the Director and Deputy Director, Office of Compliance, CDER.
* * * * *
    (c) *  *  *
    (3) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER; the

[[Page 2555]]

Directors of the Offices of Drug Evaluation I, II, III, IV, and V, 
Office of Review Management, CDER; and the Director and Deputy 
Director, Office of Compliance, CDER.
* * * * *
    7. Section 5.31 is amended by revising paragraphs (a)(2)(i) through 
(a)(2)(iii), (b)(1) through (b)(3), (c)(1), (d)(1), (d)(2), (e)(4), the 
introductory text of paragraph (f)(2), (f)(3), and (f)(5)(ii); by 
removing paragraph (a)(2)(iv); and by adding new paragraph (d)(3) to 
read as follows:


Sec. 5.31  Petitions under part 10.

    (a) *  *  *
    (2)(i) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors of the Offices of Drug Evaluation I, II, III, 
IV, and V, Office of Review Management, CDER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.
    (b) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (2) The Director, Office of Drug Evaluation V, Office of Review 
Management, CDER.
    (3) The Director and Deputy Director, Division of Over-the-Counter 
Drug Products, Office of Drug Evaluation V, Office of Review 
Management, CDER.
    (c) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
* * * * *
    (d) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (2) The Director, Office of Drug Evaluation V, Office of Review 
Management, CDER.
    (3) The Director and Deputy Director, Division of Over-the-Counter 
Drug Products, Office of Drug Evaluation V, Office of Review 
Management, CDER.
    (e) *  *  *
    (4) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER, are authorized 
to issue 180-day tentative responses to citizen petitions on drug 
product matters under Sec. 10.30(e)(2)(iii) of this chapter that relate 
to the assigned functions of that Center.
* * * * *
    (f) *  *  *
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER, are authorized 
to grant or deny citizen petitions submitted under Sec. 10.30 of this 
chapter on drug product matters in program areas where they have been 
delegated final approval authority in the following sections of this 
part:
* * * * *
    (3) The Director and Deputy Director, Division of Bioequivalence, 
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.
* * * * *
    (5) *  *  *
    (ii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, CDER.
* * * * *
    8. Section 5.33 is amended by revising paragraph (c) to read as 
follows:


Sec. 5.33  Premarket approval of a product that is or contains a 
biologic, a device, or a drug.

* * * * *
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Directors of the Offices of 
Drug Evaluation I, II, III, IV, and V, Office of Review Management, 
CDER.
    9. Section 5.37 is amended by revising paragraphs (a)(5)(i) and 
(a)(5)(ii) and by adding new paragraphs (a)(5)(iii) and (a)(5)(iv) to 
read as follows:


Sec. 5.37  Issuance of reports of minor violations.

    (a) *  *  *
    (5)(i) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Director and Deputy Director, Office of Compliance, CDER.
    (iii) The Associate Director for Medical Policy, CDER.
    (iv) The Director, Division of Drug Marketing, Advertising, and 
Communications, Office of Drug Evaluation I, Office of Review 
Management, CDER.
* * * * *
    10. Section 5.38 is amended by revising paragraphs (a)(1) through 
(a)(6) to read as follows:


Sec. 5.38  Issuance of written notices concerning patent information, 
current good manufacturing practices and false or misleading labeling 
of new drugs, new animal drugs, and feeds bearing or containing new 
animal drugs.

    (a) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (2) The Director and Deputy Director, Office of Compliance, CDER.
    (3) The Director and Deputy Director, Division of Labeling and 
Nonprescription Drug Compliance, Office of Compliance, CDER.
    (4) The Director and Deputy Director, Division of Manufacturing and 
Product Quality, Office of Compliance, CDER.
    (5) The Director and Deputy Director, Division of Prescription Drug 
Compliance and Surveillance, Office of Compliance, CDER.
    (6) The Director and Deputy Director, Division of Scientific 
Investigations, Office of Compliance, CDER.
* * * * *
    11. Section 5.44 is amended by revising paragraphs (a)(1)(iii) and 
(b)(1)(iii) to read as follows:


Sec. 5.44  Export of unapproved drugs.

    (a) *  *  *
    (1) *  *  *
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
* * * * *
    (b) *  *  *
    (1) *  *  *
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, CDER.
* * * * *
    12. Section 5.45 is amended by revising paragraph (f)(2) to read as 
follows:


Sec. 5.45  Imports and exports.

* * * * *
    (f) *  *  *
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER) and the Director and Deputy Director, 
Office of Compliance, CDER.
    13. Section 5.54 is amended by revising paragraph (c) to read as 
follows:

[[Page 2556]]

Sec. 5.54  Determinations that medical devices present unreasonable 
risk of substantial harm.

* * * * *
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.
    14. Section 5.55 is amended by revising paragraph (c) to read as 
follows:


Sec. 5.55  Orders to repair or replace, or make refunds for, medical 
devices.

* * * * *
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.
    15. Section 5.56 is amended by revising paragraph (c) to read as 
follows:


Sec. 5.56  Recall authority.

* * * * *
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.
* * * * *
    16. Section 5.57 is amended by revising paragraph (d) to read as 
follows:


Sec. 5.57  Temporary suspension of a medical device application.

* * * * *
    (d) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); the Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER; 
the Director and Deputy Director, Office of Generic Drugs, Office of 
Pharmaceutical Science, CDER; and the Director and Deputy Director, 
Office of Compliance, CDER.
* * * * *
    17. Section 5.58 is amended by revising paragraphs (c)(1)(i) 
through (c)(1)(iii) and by removing paragraph (c)(1)(iv) to read as 
follows:


Sec. 5.58  Orphan products.

* * * * *
    (c) *  *  *
    (1) *  *  *
    (i) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors of the Offices of Drug Evaluation I, II, III, 
IV, and V, Office of Review Management, CDER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.
* * * * *
    18. Section 5.60 is amended by removing paragraphs (a)(10) and 
(b)(9), by redesignating paragraphs (a)(11) through (a)(13) as 
paragraphs (a)(10) through (a)(12), and (b)(10) through (b)(12) as 
paragraphs (b)(9) through (b)(11), by revising paragraphs (a)(7) 
through (a)(9), and paragraphs (b)(6) through (b)(8) to read as 
follows:


Sec. 5.60  Required and discretionary postmarket surveillance.

    (a) *  *  *
    (7) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (8) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (9) The Director and Deputy Director, Office of Compliance, CDER.
* * * * *
    (b) *  *  *
    (6) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (7) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (8) The Director and Deputy Director, Office of Compliance, CDER.
* * * * *
    19. Section 5.70 is revised to read as follows:


Sec. 5.70  Issuance of notice implementing the provisions of the Drug 
Amendments of 1962.

    The Director, Deputy Center Director for Review Management, and 
Deputy Director, Center Director for Pharmaceutical Science, Center for 
Drug Evaluation and Research (CDER), are authorized to issue notices 
and amendments thereto implementing section 107(c)(3) of the Drug 
Amendments of 1962 (Pub. L. 87-781) by announcing new or revised 
efficacy findings on human drugs that are or were subject to the 
provisions of sections 505 and 507 of the Federal Food, Drug, and 
Cosmetic Act.
    20. Section 5.71 is amended by revising paragraphs (a)(2), (b)(1), 
(b)(2), (c)(1), and (c)(2) to read as follows:


Sec. 5.71  Termination of exemptions for new drugs for investigational 
use in human beings and in animals.

    (a) *  *  *
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) *  *  *
    (1) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (2) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.
* * * * *
    (c) *  *  *
    (1) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (2) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.
* * * * *
    21. Section 5.72 is amended by revising paragraph (a) to read as 
follows:


Sec. 5.72  Authority to approve and to withdraw approval of a charge 
for investigational new drugs.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
* * * * *
    22. Section 5.73 is amended by revising paragraphs (a) through (d) 
and by adding new paragraphs (e) and (f) to read as follows:


Sec. 5.73  Certification of insulin.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director, Office of Drug Evaluation II, Office of Review 
Management, CDER.
    (c) The Director and Deputy Director, Division of Metabolism and 
Endocrine Drug Products, Office of Drug Evaluation II, Office of Review 
Management, CDER.
    (d) The Director and Deputy Director, Office of Compliance, CDER.
    (e) The Director and Deputy Director, Division of Prescription Drug 
Compliance and Surveillance, Office of Compliance, CDER.
    (f) The Team Leader and Assistant, Post-Marketing Surveillance 
Team, Division of Prescription Drug

[[Page 2557]]

Compliance and Surveillance, Office of Compliance, CDER.
    23. Section 5.74 is amended by revising paragraphs (a) and (b) and 
by adding new paragraphs (c) and (d) to read as follows:


Sec. 5.74  Issuance, amendment, or repeal of regulations pertaining to 
drugs containing insulin.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director, Office of Drug Evaluation II, Office of Review 
Management, CDER.
    (c) The Director and Deputy Director, Division of Metabolism and 
Endocrine Drug Products, Office of Drug Evaluation II, Office of Review 
Management, CDER.
    (d) The Director and Deputy Director, Office of Compliance, CDER.
    24. Section 5.75 is amended by revising paragraphs (a) through (c) 
to read as follows:


Sec. 5.75  Designation of official master and working standards for 
antibiotic drugs.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Office of Testing and 
Research, Office of Pharmaceutical Science, CDER.
    (c) The Director and Deputy Director, Division of Research and 
Testing, Office of Testing and Research, Office of Pharmaceutical 
Science, CDER.
    25. Section 5.76 is amended by revising paragraphs (a) through (d) 
to read as follows:


Sec. 5.76  Certification of antibiotic drugs.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Office of Compliance, CDER.
    (c) The Director and Deputy Director, Division of Prescription Drug 
Compliance and Surveillance, Office of Compliance, CDER.
    (d) The Team Leader and Assistant, Post-Marketing Surveillance 
Team, Division of Prescription Drug Compliance and Surveillance, Office 
of Compliance, CDER.
    26. Section 5.78 is amended by revising paragraphs (a)(1) and 
(a)(2) and adding new paragraphs (a)(3) through (a)(7) to read as 
follows:


Sec. 5.78  Issuance, amendment, or repeal of regulations pertaining to 
antibiotic drugs.

    (a) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (2) The Director, Office of Drug Evaluation I, Office of Review 
Management, CDER.
    (3) The Director, Office of Drug Evaluation IV, Office of Review 
Management, CDER.
    (4) The Director and Deputy Director, Division of Oncologic Drug 
Products, Office of Drug Evaluation I, Office of Review Management, 
CDER.
    (5) The Director and Deputy Director, Division of Anti-Infective 
Drug Products, Office of Drug Evaluation IV, Office of Review 
Management, CDER.
    (6) The Director and Deputy Director, Division of Anti-Viral Drug 
Products, Office of Drug Evaluation IV, Office of Review Management, 
CDER.
    (7) The Director and Deputy Director, Office of Compliance, CDER.
* * * * *
    27. Section 5.80 is amended by revising paragraphs (a)(1)(i), 
(a)(1)(ii), (b), (c)(1)(i) and (c)(1)(ii), (d)(1) through (d)(3), the 
first sentence in paragraph (e), and paragraph (f) and by removing 
paragraphs (a)(1)(iii), (c)(1)((iii), and (c)(1)(iv) to read as 
follows:


Sec. 5.80  Approval of new drug applications and their supplements.

    (a)(1) *  *  *
    (i) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors of the Offices of Drug Evaluation I, II, III, 
IV, and V, Office of Review Management, CDER, for drugs under their 
jurisdiction.
* * * * *
    (b) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER, for drugs under their jurisdiction, are authorized to 
perform all functions of the Commissioner of Food and Drugs with regard 
to approval of supplemental applications to approved new drug 
applications for drugs for human use that have been submitted under 
Sec. 314.70 of this chapter and of new drug applications for drug 
products other than those that contain new molecular entities (new 
chemical entities). The applications to which this authorization 
applies may, in appropriate circumstances, continue to be acted upon by 
the officials so authorized in Sec. 5.10(a) and paragraph (a) of this 
section.
    (c) *  *  *
    (1) *  *  *
    (i) The Director and Deputy Director, Office of Generic Drugs 
(OGD), Office of Pharmaceutical Science, CDER, except that the Director 
and Deputy Director, OGD are not authorized to approve new drug 
applications with a 5S classification if clinical studies are needed.
    (ii) The Directors and Deputy Directors of the divisions in Offices 
of Drug Evaluation I, II, III, IV, and V, Office of Review Management, 
CDER.
    (d) *  *  *
    (1) The Director and Deputy Director, Division of Chemistry I, 
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
    (2) The Director and Deputy Director, Division of Chemistry II, 
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
    (3) Associate Director for Chemistry, Office of Pharmaceutical 
Science, CDER.
    (e) The Director, Division of Labeling and Program Support, Office 
of Generic Drugs, Office of Pharmaceutical Science, CDER, are 
authorized to perform all the functions of the Commissioner of Food and 
Drugs with respect to approval of supplemental applications to 
abbreviated new drug applications, 5S applications, or 505(b)(2) 
applications for drugs for human use that are described in 
Sec. 314.70(b)(3) and (c)(2)(i) through (c)(2)(iv) of this chapter. * * 
*
    (f) The supervisory and team leader chemists in the Divisions of 
New Drug Chemistry I, II, and III, Office of New Drug Chemistry, Office 
of Pharmaceutical Science, CDER, are authorized to perform all 
functions of the Commissioner of Food and Drugs with respect to 
approval of supplemental applications to new drug applications for 
drugs for human use that are described in Sec. 314.70(b)(1), (b)(2)(ii) 
through (b)(2)((x), (c)(1), and (c)(3) of this chapter. Authority to 
approve supplements that require in vivo bioavailability information or 
that require a change in the labeling of the drug, except changes that 
reflect only the use of a different facility or establishment, are not 
included in this paragraph. The supplemental applications to which this 
authorization applies may continue to be acted upon by the officials so 
authorized in Sec. 5.10(a) and paragraphs (a) and (b) of this section.
    28. Section 5.82 is amended by revising paragraph (a) to read as 
follows:

[[Page 2558]]

Sec. 5.82  Issuance of notices relating to proposals to refuse approval 
or to withdraw approval of new drug applications and their supplements.

    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER), are authorized to issue notices of an 
opportunity for a hearing on proposals to refuse approval or to 
withdraw approval of new drug applications and abbreviated new drug 
applications and supplements thereto on drugs for human use, except for 
those drugs listed in Sec. 314.440(b) of this chapter, that have been 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act 
and subpart B of part 314 of this chapter and to issue notices refusing 
approval or withdrawing approval when opportunity for hearing has been 
waived.
 * * * * *
    29. Section 5.93 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec. 5.93  Submission of and effective approval dates for abbreviated 
new drug applications and certain new drug applications.

* * * * *
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Division of Bioequivalence, 
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
    30. Section 5.94 is amended by revising paragraphs (b)(1) through 
(b)(3) and by removing paragraph (b)(4) to read as follows:


Sec. 5.94  Extensions or stays of effective dates for compliance with 
certain labeling requirements for human prescription drugs.

* * * * *
    (b) *  *  *
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (2) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (3) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.

    Dated: December 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-1202 Filed 1-16-97; 8:45 am]
BILLING CODE 4160-01-F