[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Rules and Regulations]
[Pages 59617-59618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations of Authority and Organization; Office of the
Commissioner and the 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
delegations of authority statement that covers general redelegations of
authority from the Commissioner of Food and Drugs to other officers of
FDA. The amendment delegates authority to perform all functions
relating to waivers or reductions of prescription drug user fees under
the Prescription Drug User Fee Act of 1992 (PDUFA), as originally
enacted and as reauthorized by the FDA Modernization Act of 1997 (the
Modernization Act), to the Director, Center for Drug Evaluation and
Research (CDER) and to the Associate Director for Policy, CDER, except
for the functions that pertain to situations where ``the fees will
exceed the anticipated present and future costs.'' The authority to
waive or reduce user fees, previously redelegated to the Chief Mediator
and Ombudsman/User Fee Waiver Officer, the Deputy Chief Mediator and
Ombudsman, and the Deputy User Fee Waiver Officer is hereby revoked,
except the authority to act upon requests for reconsideration of any
user fee decision made by such officers prior to July 1, 1999. Also, as
a result of the June 20, 1999, FDA reorganization, the Office of
Operations component and the Deputy Commissioner for Operations
position were abolished; therefore, the Deputy Commissioner will assume
the role of the User Fee Appeals Officer and perform the associated
functions.
EFFECTIVE DATE: July 1, 1999.
ADDRESSES: As of July 1, 1999, submit all requests for waivers,
refunds, and reductions in user fees under PDUFA, originally enacted
and reauthorized by the Modernization Act, to the Associate Director
for Policy, Center for Drug Evaluation and Research (HFD-5), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Attn: User
Fee Waiver Office. Submit requests sent via a courier that requires a
street address to the Associate Director for Policy, Center for Drug
Evaluation and Research (HFD-5), Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20852, Attn: User Fee Waiver Office.
Submit requests for reconsideration of user fee waiver determinations
made prior to the effective date of this document to the Office of the
Chief Mediator and Ombudsman, (HF-7), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Beverly J. Friedman, User Fee Staff (HFD-5), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041,
or
Donna G. Page, Division of Management Programs (HFA-340),
[[Page 59618]]
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-4816.
SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority
under Sec. 5.20 General redelegations of authority from the
Commissioner to other officers of the Food and Drug Administration (21
CFR 5.20) by revising Sec. 5.20(h) to revoke the authority of the Chief
Mediator and Ombudsman/User Fee Waiver Officer, the Deputy Chief
Mediator and Ombudsman, and the Deputy User Fee Waiver Officer to waive
or reduce user fees under the waiver provisions of PDUFA as originally
enacted and as amended by the Modernization Act (section 736(d) and
(a)(1)(G) of the Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
379h(d) and (a)(1)(G)), except the authority to act upon requests for
reconsideration of any user fee decision made by such officers prior to
July 1, 1999. FDA is also revising the section to reflect that the
Deputy Commissioner is designated as the User Fee Appeals Officer and
in the case of a vacancy in the position, to reflect the designation of
the Senior Associate Commissioner, Office of the Commissioner as the
User Fee Appeals Officer.
FDA is adding Sec. 5.101 Authority relating to waivers or
reductions of prescription drug user fees to reflect redelegation of
certain user fee-related authorities under section 736(d) and (a)(1)(G)
of the act, as amended, to the Director, CDER and to the Associate
Director for Policy, CDER. CDER will exercise the authority now being
delegated to resolve requests for waivers, reductions, or refunds of
assessable fees relating to human drug products reviewed and regulated
by CDER, the Center for Biologics Evaluation and Research, and any
other FDA center.
Authority delegated to a position by title may be exercised by a
person officially designated to serve in such a 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. These authorities may not be further redelegated.
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.
2. Section 5.20 is amended by revising paragraph (h) to read as
follows:
Sec. 5.20 General redelegations of authority from the Commissioner to
other officers of the Food and Drug Administration.
* * * * *
(h)(1) The Chief Mediator and Ombudsman and the Deputy Chief
Mediator and Ombudsman are authorized to act upon requests for
reconsideration of any user fee decisions (under 21 U.S.C. 379h(d))
made by such officers and the former Deputy User Fee Waiver Officer
prior to July 1, 1999. This authority may not be further redelegated.
(See Sec. 5.101 for the user fee-related redelegation to officials
within the Center for Drug Evaluation and Research.)
(2) The Deputy Commissioner for Management and Systems and the
Director, Office of Financial Management are authorized to perform the
functions of the Commissioner under 21 U.S.C. 379h(d)(1)(C), as
amended, to waive or reduce prescription drug user fees in situations
where he/she finds that ``the fees will exceed the anticipated present
and future costs.'' This authority may not be further redelegated.
(3) The Deputy Commissioner or, in the event of a vacancy in that
position, the Senior Associate Commissioner, Office of the
Commissioner, is designated as the User Fee Appeals Officer. The User
Fee Appeals Officer is authorized to hear and decide user fee waiver
appeals. The decision of the User Fee Appeals Officer will constitute
final agency action on such matters. This authority may not be further
redelegated.
3. Section 5.101 is added to subpart C to read as follows:
Sec. 5.101 Authority relating to waivers or reductions of prescription
drug user fees.
The Director, Center for Drug Evaluation and Research (CDER), and
the Associate Director for Policy, CDER, are authorized to perform all
functions of the Commissioner of Food and Drugs relating to waivers or
reductions of prescription drug user fees under the Prescription Drug
User Fee Act of l992, as originally enacted and as reauthorized by the
FDA Modernization Act of l997, except for the functions under 21 U.S.C.
379h(d)(1)(C) that pertain to situations where ``the fees will exceed
the anticipated present and future costs,'' on behalf of CDER, the
Center for Biologics Evaluation and Research, and any other FDA center.
This authority pertains to waivers requested under the public health
waiver provision (21 U.S.C. 379h(d)(1)(A)); the barrier to innovation
waiver provision (21 U.S.C. 379h(d)(1)(B)); the applications submitted
under section 505(b)(1) and (b)(2) of the Federal Food, Drug, and
Cosmetic Act waiver provision (21 U.S.C. 379h(d)(1)(D)); the small
business waiver provision (21 U.S.C. 379h(d)(1)(E)); and to requests
for refunds of fees if an application or supplement is withdrawn after
filing (21 U.S.C. 379h(a)(1)(G)); as well as waivers, reductions, or
refunds requested on any other basis except fees exceeding the cost.
These authorities may not be further redelegated. (See Sec. 5.20(h)(1)
for the authority to reconsider any user fee decisions made by the
Chief Mediator and Ombudsman, the Deputy Chief Mediator and Ombudsman,
and/or the former Deputy User Fee Waiver Officer prior to July 1,
1999.)
* * * * *
Dated: October 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28562 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F
