[Federal Register Volume 65, Number 45 (Tuesday, March 7, 2000)]
[Notices]
[Pages 12019-12020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0297]


Guidance for Industry on Formal Dispute Resolution: Appeals Above 
the Division Level; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Formal Dispute 
Resolution: Appeals Above the Division Level.'' This guidance is 
intended to provide guidance for industry on procedures that will be 
adopted by the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) for resolving 
scientific and procedural disputes that cannot be resolved at the 
division level.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm. Submit written requests for single 
copies of the guidance to the Drug Information Branch (HFD-210), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448, 
301-827-3844, FAX 888-CBERFAX. Send two self-addressed adhesive labels 
to assist that office in processing your requests. Submit written 
comments on the guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Patricia L. DeSantis, Center for Drug Evaluation and Research (HFD-
2), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5400, or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance entitled ``Formal Dispute Resolution: Appeals Above the 
Division Level.'' The guidance is intended to provide guidance for 
industry on procedures that will be adopted by CDER and CBER for 
resolving scientific and procedural disputes that cannot be resolved at 
the division level. The guidance describes procedures for formally 
appealing such disputes to the office or center level and for 
submitting information to assist agency officials in resolving the 
issue(s) presented.
    In the Federal Register of March 19, 1999 (64 FR 13587), FDA 
announced the availability of a draft guidance for industry entitled 
``Formal Dispute Resolution: Appeals Above the Division Level.'' The 
agency has finalized this guidance after considering comments received 
on the draft version. Few comments were received, and minor changes 
were made to the draft version in response to the comments in an effort 
to make the document more clear.
    FDA regulations 21 CFR 10.75 provide a mechanism for any interested 
person to obtain formal review of any agency decision by raising the 
matter with the supervisor of the employee who made the decision. If 
the issue is not resolved at the primary supervisory level, the 
interested person may request that the matter be reviewed at the next 
higher supervisory level. This process may continue through the 
agency's entire supervisory chain of command, through the centers to 
the Commissioner of Food and Drugs. CDER and CBER regulations for 
dispute resolution during the investigational new drug process (21 CFR 
312.48) and the new drug application/abbreviated new drug application 
process (21 CFR 314.103) establish similar procedures for the 
resolution of scientific and procedural matters at the division level 
and subsequent formal review of decisions through center management.
    On November 21, 1997, President Clinton signed into law the Food 
and Drug Administration Modernization Act of 1997 (the Modernization 
Act) (Public Law 105-115). Section 404 of the Modernization Act creates 
new section 562 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360bbb-1). Section 562 of the act provides that if, 
regarding an obligation concerning drugs or devices under the act or 
section 351 of the Public Health Service Act (42 U.S.C. 262), there is 
a scientific dispute between the agency and a sponsor, applicant, or 
manufacturer and no specific provision of the act or regulation 
provides a right of review of the matter in controversy, FDA shall, by 
regulation, establish a procedure under which such sponsor, applicant, 
or manufacturer may request a review of the controversy, including

[[Page 12020]]

review by an advisory committee. Section 562 of the act further 
provides that such review of the controversy shall take place in a 
timely manner. In the Federal Register of November 18, 1998 (63 FR 
63978), FDA amended 21 CFR 10.75 to explicitly state that a sponsor, 
applicant, or manufacturer of a drug or device may request review of a 
scientific controversy by an appropriate advisory committee. In the 
preamble to the final rule, FDA stated that implementation of this 
provision would be undertaken by the individual FDA centers and would 
be described in guidance documents.
    The Prescription Drug User Fee Act of 1992 (Public Law 102-571) 
(PDUFA) was reauthorized in November 1997 (PDUFA 2) as part of the 
Modernization Act. In conjunction with PDUFA 2, FDA agreed to specific 
performance goals (PDUFA goals) for activities associated with the 
development and review of products in human drug applications as 
defined in section 735(1) of the act (21 U.S.C. 379g(1)) (PDUFA 
products). The PDUFA goals are summarized in ``PDUFA Reauthorization 
Performance Goals and Procedures,'' an enclosure to a letter dated 
November 12, 1997, from the Secretary of Health and Human Services, 
Donna E. Shalala, to Senator James M. Jeffords. The PDUFA goals for 
major dispute resolution describe specific timeframes for CDER and CBER 
response to formally appealed decisions regarding scientific or 
procedural matters concerning PDUFA products.
    The policies and procedures described in this guidance document 
will implement agency regulations, section 562 of the act, and the 
PDUFA goals for dispute resolution. Unless stated otherwise in the 
guidance, the document applies to PDUFA products and non-PDUFA products 
(e.g., generic drugs).
    In the notice announcing the availability of the draft version of 
this guidance, FDA published notice of the proposed collection of 
information related to the guidance. The Federal Register notice also 
requested comments on the burden estimates for the guidance document. 
In the Federal Register of August 15, 1999 (64 FR 46397), the agency 
announced that it was submitting the collection of information to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995. The information collection 
provisions related to this guidance document have been approved under 
OMB control number 0910-0430. This approval expires December 31, 2002. 
An agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance 
represents the agency's current thinking on formal dispute resolution 
in CDER and CBER. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 29, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5465 Filed 3-6-00; 8:45 am]
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