[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
