[Federal Register Volume 67, Number 96 (Friday, May 17, 2002)]
[Notices]
[Page 35122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0084]


Guidance for Industry on Special Protocol Assessment; 
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 ``Special Protocol 
Assessment.'' This guidance provides guidance for industry on 
procedures adopted by the Center for Drug Evaluation and Research 
(CDER) and the Center for Biologics Evaluation and Research (CBER) to 
evaluate issues related to the adequacy (e.g., design, conduct, 
analysis) of certain proposed studies.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), 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, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, FAX 888-CBERFAX or 301-827-3844. Send two self-addressed 
adhesive labels to assist the office in processing your requests. 
Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Kim M. Colangelo, 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:

I. Background

    In the Federal Register of February 9, 2000 (65 FR 6377), FDA 
announced the availability of a draft version of this guidance for 
industry entitled ``Special Protocol Assessment.'' The agency has 
finalized that draft guidance after considering comments received on 
the draft guidance version. Eight comments were received, and minor 
changes were made to the draft guidance version in an effort to make 
the document more clear.
    Section 119(a) of the Food and Drug Administration Modernization 
Act of 1997 (the Modernization Act) (Public Law 105-115) amends section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
and directs FDA to allow sponsors to request special protocol 
assessment and for the agency to act on such requests. Moreover, in 
conjunction with the reauthorization of the Prescription Drug User Fee 
Act of 1992 in November 1997, FDA agreed to specific performance goals 
for special protocol assessment and agreement. The performance goals 
are summarized in an enclosure to a letter dated November 12, 1997, 
from the then Secretary of Health and Human Services, Donna E. Shalala, 
to Senator James E. Jeffords.
    The procedures and policies described in this guidance were adopted 
by CDER and CBER for evaluating issues related to the adequacy (e.g., 
design, conduct, analysis) of proposed studies. These procedures will 
implement section 119(a) of the Modernization Act and are consistent 
with the timeframes described in the performance goals.
    In the Federal Register document (65 FR 6377) announcing the 
availability of the draft version of this guidance, FDA published the 
proposed collection of information related to the draft guidance. The 
document also requested comments on the burden estimates for the draft 
guidance. In the Federal Register of May 29, 2001 (66 FR 29147), 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 have been approved under OMB 
control number 0910-0470. This approval expires July 31, 2004. 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 (21 CFR 10.115). The guidance represents the 
agency's current thinking on special protocol assessment 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 and regulations. The guidance will be updated as appropriate.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
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 may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder.guidance/index.htm, or http://www.fda.gov/cber/guidelines.htm.

    Dated: May 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12327 Filed 5-16-02; 8:45 am]
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