[Federal Register Volume 65, Number 106 (Thursday, June 1, 2000)]
[Rules and Regulations]
[Pages 34959-34963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the general 
redelegations of authority from the Commissioner of Food and Drugs to 
other officers of FDA. On June 20, 1999, the Commissioner of Food and 
Drugs restructured FDA ``to create a more streamlined and efficient 
Office of the Commissioner that will provide leadership without 
compromising programmatic effectiveness.'' In this restructuring, 
organizational

[[Page 34960]]

components were abolished and established and functions and personnel 
were transferred. Therefore, FDA is updating the delegations of 
authority regulations to reflect these changes and to delegate 
authority to positions in newly established components. FDA is also 
updating some position titles that may have been affected by previous 
reorganizations.

DATES:  This rule is effective June 1, 2000.

FOR FURTHER INFORMATION CONTACT: Donna G. Page, Division of Management 
Programs (HFA-330), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4816.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority 
regulations in various sections of 21 CFR part 5, subpart B, 
Redelegations of Authority from the Commissioner of Food and Drugs, to 
reflect the most significant changes that resulted from the June 20, 
1999, restructuring. (See 64 FR 36361-36368, July 6, 1999, and 64 FR 
38675, July 19, 1999.) The changes are as follows:
    1. Updating the order of succession and who may perform all of the 
functions of the Commissioner of Food and Drugs.
    2. Clarifying certain delegations of authority to appropriately 
reflect the Deputy Commissioners' authorities--there will be one 
principal Deputy Commissioner; however, two other Deputy Commissioner 
titles (International and Constituent Relations and Management and 
Systems) will be retained for incumbents only.
    3. Amending certain delegations of authority and associated 
position titles to reflect the establishment of the Office of the 
Senior Associate Commissioner and the transfer of the Ombudsman, 
Executive Secretariat, Advisory Committee Oversight, Public Affairs, 
and Orphan Products Development functions to that component.
    4. Removing position titles and delegations of authority associated 
with the abolished Office of Operations.
    5. Removing references to the abolished Offices of Policy and 
External Affairs and updating position titles and associated 
delegations of authority, where appropriate, to reflect their 
conversions to the Office of Policy, Planning, and Legislation and the 
Office of International and Constituent Relations, respectively.
    6. Updating position titles and associated delegations of authority 
to reflect the transfer of the health assessment, patent term 
extension, and scheduling controlled substances functions to the Center 
for Drug Evaluation and Research.
    7. Updating position titles and associated delegations of authority 
to reflect the transfer of 21 CFR part 16 hearings functions; and to 
reflect the delegation of authority to make due diligence 
determinations, which pertain to patent term extensions, to the Office 
of the Ombudsman.
    Unless stated otherwise, these authorities may not be further 
redelegated. 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, unless prohibited by a 
restriction in the document designating him/her as ``acting'' or unless 
not legally permissible.

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 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.


    2. Section 5.20 is amended by revising paragraphs (b), (c), (e), 
(f), and (g); by redesignating paragraph (i) as paragraph (j); and by 
adding a new paragraph (i) to read as follows:


Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

* * * * *
    (b) The following officials are authorized to perform all of the 
functions of the Commissioner of Food and Drugs and this authority may 
not be further redelegated:
    (1) Deputy Commissioner;
    (2) Associate Commissioner for Regulatory Affairs;
    (3) Senior Associate Commissioner;
    (4) Deputy Commissioner for Management and Systems;
    (5) Senior Associate Commissioner for Policy, Planning, and 
Legislation; and
    (6) Deputy Commissioner for International and Constituent 
Relations.
    (c)(1) During the absence or disability of the Commissioner, or in 
the event of a vacancy in that position, the first official who is 
available in the following positions, or who has been designated by the 
Commissioner to act in such position, shall act as Commissioner:
    (i) Deputy Commissioner;
    (ii) Associate Commissioner for Regulatory Affairs; or
    (iii) Senior Associate Commissioner.
    (2) This authority may not be further redelegated. However, for a 
planned period of absence, the Commissioner of Food and Drugs (or 
someone ``acting'' on his/her behalf) may specify a different order of 
succession.
* * * * *
    (e)(1) The Senior Associate Commissioner is authorized to make 
determinations that advisory committee meetings are concerned with 
matters listed in 5 U.S.C. 552(b) and therefore may be closed to the 
public in accordance with Sec. 5.10(a)(18). This authority may not be 
further redelegated.
    (2) The Senior Associate Commissioner is authorized to perform 
other associated advisory committee functions (e.g., establishing 
technical and scientific review groups (advisory committees)); 
appointing and paying members; approving waivers to appoint members to 
established advisory committees; renewing and rechartering of 
established advisory committees; amending charters of established 
advisory committees; and terminating established advisory committees. 
This authority may not be further redelegated.
    (3) The Senior Associate Commissioner is authorized to approve 
conflict of interest waivers for special Government employees serving 
on advisory committees in accordance with 18 U.S.C. 208(b)(3), as 
amended. This authority may not be further redelegated.
    (4) The Senior Associate Commissioner is authorized to select 
temporary members to advisory committees if such voting members are 
serving on an advisory committee managed by another center. This 
authority may not be further redelegated.
    (f)(1) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy are authorized to 
perform any of the functions of the Commissioner of Food and Drugs with 
respect to the issuance of Federal Register notices and proposed and 
final

[[Page 34961]]

regulations of the Food and Drug Administration. This authority may not 
be further redelegated.
    (2) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy are authorized to 
issue responses to the following matters under part 10 of this chapter 
as follows, and this authority may not be further redelegated:
    (i) Requests for waiver, suspension, or modification of procedural 
requirements under Sec. 10.19 of this chapter;
    (ii) Citizen petitions under Sec. 10.30 of this chapter;
    (iii) Petitions for reconsideration under Sec. 10.33 of this 
chapter;
    (iv) Petitions for stay under Sec. 10.35 of this chapter; or
    (v) Requests for advisory opinions under Sec. 10.85 of this 
chapter.
    (3) With respect to any matter delegated to the Senior Associate 
Commissioner for Policy, Planning, and Legislation and the Associate 
Commissioner for Policy under paragraph (f) of this section, the Senior 
Associate Commissioner for Policy, Planning, and Legislation and the 
Associate Commissioner for Policy are authorized to perform the 
function of the Commissioner of Food and Drugs under Secs. 10.40, 
10.45, 10.50, 10.55, 10.60, 10.65, 10.80, 10.90, and 10.95 of this 
chapter and of the Deputy Commissioner under Sec. 10.206(g) and (h) of 
this chapter. This authority may not be further redelegated.
    (4) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy are authorized 
under the Regulatory Flexibility Act (5 U.S.C. 605(b)) to certify that 
a proposed or final rule, if issued, will not have a significant 
economic impact on a substantial number of small entities. This 
authority may be further redelegated.
    (g) The following officials are authorized to perform all of the 
functions of the officials under them in their respective offices, and 
this authority may not be further redelegated:
    (1) Senior Associate Commissioner;
    (2) Deputy Commissioner for International and Constituent 
Relations;
    (3) Deputy Commissioner for Management and Systems; or
    (4) Senior Associate Commissioner for Policy, Planning, and 
Legislation.
* * * * *
    (i) The Deputy Commissioner is authorized to perform the due 
diligence determinations and informal hearings functions under 35 
U.S.C. 156(d)(2)(B)(ii), as amended, relative to patent term 
extensions. This authority may not be further redelegated.
* * * * *

    3. Section 5.22 is amended by revising paragraphs (a)(1), (a)(2), 
(a)(3), (a)(6), (a)(7), (a)(10)(ii), (a)(11)(ii), (a)(12)(ii), (b)(1), 
(b)(2), and (b)(3); by redesignating paragraph (c) as paragraph (d) and 
revising newly redesignated paragraph (d); and by adding new paragraph 
(c) to read as follows:


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

    (a) * * *
    (1) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, and the Deputy Commissioner 
for Management and Systems.
    (2) The Senior Associate Commissioners, the Associate and Deputy 
Associate Commissioners, and the Chief Counsel and Deputies.
    (3) The Director, Office of the Executive Secretariat, Office of 
the Senior Associate Commissioner, Office of the Commissioner.
* * * * *
    (6)(i) The Director, Office of Human Resources and Management 
Services, Office of Management and Systems, Office of the Commissioner.
    (ii) The Director, Division of Management Programs, Office of Human 
Resources and Management Services, Office of Management and Systems, 
Office of the Commissioner.
    (iii) The Chief, Dockets Management Branch, Division of Management 
Programs, Office of Human Resources and Management Services, Office of 
Management and Systems, Office of the Commissioner.
    (7)(i) The Associate Commissioner for Public Affairs, Office of 
Public Affairs, Office of the Senior Associate Commissioner, Office of 
the Commissioner.
    (ii) The Director, Freedom of Information Staff, Office of Public 
Affairs, Office of the Senior Associate Commissioner, Office of the 
Commissioner.
* * * * *
    (10) * * *
    (ii) The Director and Deputy Director, Office of Management and 
Communications, Center for Veterinary Medicine (CVM).
* * * * *
    (11) * * *
    (ii) The Director and Deputy Director, Office of Management and 
Communications, CVM.
* * * * *
    (12) * * *
    (ii) The Director, Office of Management, Facilities, and Research 
Support, NCTR.
* * * * *
    (b) * * *
    (1) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, and the Deputy Commissioner 
for Management and Systems.
    (2) The Senior Associate Commissioners, the Associate and Deputy 
Associate Commissioners, and the Chief Counsel and Deputies.
    (3) The Director, Office of Human Resources and Management 
Services, Office of Management and Systems, Office of the Commissioner.
    (c) The authorities under Sec. 5.22 (a) and (b), where appropriate, 
may be further redelegated by the Deputy Commissioners; Senior 
Associate Commissioners; Associate Commissioner for Regulatory Affairs 
and Deputy; Chief Counsel and Deputies; Center Directors and Deputies; 
and Executive Officers (i.e., Executive Assistant, Office of the 
Commissioner; Director, Office of Management, CBER; Director, Office of 
Management, CDER; Director, Office of Management and Systems, CFSAN; 
Director, Office of Systems and Management, CDRH; Director, Office of 
Management and Communications, CVM; Director, Office of Management, 
Facilities, and Research Support, NCTR; and the Director, Office of 
Resource Management, ORA).
    (d) The Chief, Regulations Editorial Section; Regulations Policy 
and Management Staff; Office of Policy, Planning, and Legislation; 
Office of the Commissioner, and his/her alternates are authorized to 
certify true copies of Federal Register documents. The Chief, 
Regulations Editorial Section; Regulations Policy and Management Staff; 
Office of Policy, Planning, and Legislation; and the Office of the 
Commissioner may designate alternates as required.

    4. Section 5.23 is amended by revising paragraphs (a)(1), (a)(2), 
(a)(4), and (d).


Sec. 5.23  Disclosure of official records.

    (a) * * *
    (1) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, the Deputy Commissioner for 
Management and Systems, Senior Associate Commissioners, Associate and 
Deputy Associate Commissioners.
    (2)(i) The Executive Assistant to the Commissioner, Office of the 
Commissioner.
    (ii) The Director, Office of the Executive Secretariat, Office of 
the

[[Page 34962]]

Senior Associate Commissioner, Office of the Commissioner.
* * * * *
    (4)(i) The Director, Office of Human Resources and Management 
Services, Office of Management and Systems, Office of the Commissioner.
    (ii) The Director, Division of Management Programs, Office of Human 
Resources and Management Services, Office of Management and Systems, 
Office of the Commissioner.
    (iii) The Chief, Dockets Management Branch, Division of Management 
Programs; Office of Human Resources and Management Services, Office of 
Management Services, Office of the Commissioner.
* * * * *
    (d) The Director, Office of Resource Management, Office of 
Regulatory Affairs is authorized to sign affidavits regarding the 
presence or absence of records in the files of that office.
* * * * *

    5. Section 5.25 is amended by revising paragraphs (a)(7) and (c) to 
read as follows:


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

    (a) * * *
    (7) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner.
* * * * *
    (c) The Deputy Commissioner for Management and Systems, Office of 
Management and Systems, Office of the Commissioner; the Director and 
Deputy Director, Office of Facilities, Acquisitions, and Central 
Services, Office of Management and Systems, Office of the Commissioner; 
the Director, Division of Contracts and Procurement Management, Office 
of Facilities, Acquisitions, and Central Services, Office of Management 
and Systems, Office of the Commissioner; and the Chief Grants 
Management Officer and the Grants Management Officer, Division of 
Contracts and Procurement Management, Office of Facilities, 
Acquisitions, and Central Services, Office of Management Systems, 
Office of the Commissioner are authorized to sign and issue all notices 
of grant awards and amendments thereto and sign and issue notices of 
suspension and termination thereof for grants approved under the 
authority delegated in paragraphs (a) and (b) of this section.
* * * * *

    6. Section 5.27 is revised to read as follows:


Sec. 5.27  Patent term extensions for human drug products, medical 
devices, and food and color additives; and due diligence 
determinations.

    (a) The Director, Center for Drug Evaluation and Research (CDER) 
and the Associate Director for Policy, CDER, are authorized to perform 
the functions delegated to the Commissioner of Food and Drugs under 35 
U.S.C. 156, as amended, except for making due diligence determinations 
and holding of informal hearings under 35 U.S.C. 156(d)(2)(B).
    (b) The Chief Mediator and Ombudsman, Office of the Ombudsman, 
Office of the Senior Associate Commissioner, Office of the 
Commissioner, is authorized to perform the functions delegated to the 
Commissioner to make due diligence determinations under 35 U.S.C. 
156(d)(2)(B), as amended, except for holding of informal hearings under 
35 U.S.C. 156(d)(2)(B)(ii).

    7. Section 5.30 is amended by revising paragraph (c)(1) to read as 
follows:


Sec. 5.30  Hearings.

* * * * *
    (c) * * *
    (1) The Chief Mediator and Ombudsman, Office of the Ombudsman, 
Office of the Senior Associate Commissioner, Office of the 
Commissioner.
* * * * *

    8. Section 5.32 is revised to read as follows:


Sec. 5.32  Authority relating to determination of product 
classification and assignment of primary jurisdiction.

    The Chief Mediator and Ombudsman, Office of the Ombudsman, Office 
of the Senior Associate Commissioner, Office of the Commissioner, as 
product jurisdiction officer is authorized to make a determination 
under section 563 of the Federal Food, Drug, and Cosmetic Act (the act) 
respecting the classification of a product as a drug, biological 
product, device, or a combination product subject to section 503(g) of 
the act, and to assign primary responsibility respecting the 
organizational component of the Food and Drug Administration that will 
regulate the product.

    9. Section 5.34 is amended by revising paragraph (a) to read as 
follows:


Sec. 5.34  Authority to select temporary voting members for advisory 
committees and authority to sign conflict of interest waivers.

    (a) Each center director is authorized to select members of, and 
consultants to, scientific and technical FDA advisory committees under 
that center's management to serve temporarily as voting members on 
another advisory committee under that center's management when 
expertise is required that is not available among current voting 
standing members of a committee or to comprise a quorum when, because 
of unforeseen circumstances, a quorum will be lacking. When additional 
voting members are added to a committee to provide needed expertise not 
available among current voting standing members of a committee, a 
quorum will be based on the total of regular and added members. 
Authority to select temporary voting members to advisory committees if 
such voting members are serving on an advisory committee managed by 
another center has not been redelegated. This authority will continue 
to be exercised by the Commissioner or the Senior Associate 
Commissioner, Office of the Commissioner.
* * * * *

    10. Section 5.58 is amended by revising introductory text of 
paragraphs (a) and (b) to read as follows:


Sec. 5.58  Orphan products.

    (a) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, is 
authorized to issue notices, and amendments thereto, inviting 
sponsorship for orphan products (human and animal drugs, biological 
products, and medical devices) and submission of:
* * * * *
    (b) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, is 
authorized:
* * * * *

    11. Section 5.81 is revised to read as follows:


Sec. 5.81  Responses to Drug Enforcement Administration temporary 
scheduling notices.

    The Director, Center for Drug Evaluation and Research (CDER) and 
the Director, Executive Operations Staff, Office of the Center 
Director, CDER are authorized to provide responses to the Drug 
Enforcement Administration's temporary scheduling notices under the 
Controlled Substances Act, as amended (Title II of the Comprehensive 
Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. 811(h)(4), as 
amended hereafter). The delegation excludes the authority to submit 
reports to Congress. Further redelegation may only be authorized with 
the Commissioner of Food and Drugs' approval.


[[Page 34963]]


    Dated: May 17, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-13586 Filed 5-31-00; 8:45 am]
BILLING CODE 4160-01-F