[Federal Register Volume 68, Number 48 (Wednesday, March 12, 2003)]
[Notices]
[Pages 11870-11871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0195]


``Guidance for FDA Staff: The Leveraging Handbook, An Agency 
Resource for Effective Collaborations''

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 document entitled ``Guidance for FDA Staff: The 
Leveraging Handbook, An Agency Resource for Effective Collaborations,'' 
dated February 2003. The guidance document is intended to provide 
information to assist FDA staff in creating and implementing effective 
collaborations consistent with relevant legal, ethical, and policy 
considerations. FDA and its stakeholders use collaborations to take 
advantage of and amplify the unique resources possessed by each to 
address a variety of public health issues. The guidance document 
enumerates factors that FDA employees should consider, and the 
procedures they should follow, when planning a leveraged collaboration. 
This guidance finalizes the draft guidance under the same title dated 
November 2001 that was announced in the Federal Register on November 
13, 2001.

DATES:  Submit written or electronic comments at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800. 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. Submit electronic comments to http://www.fda.gov/dcokets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

[[Page 11871]]

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource 
for Effective Collaborations,'' dated February 2003. The guidance 
announced in this notice finalizes the draft guidance of the title 
dated November 2001 (67 FR 56831, November 13, 2001).
    ``Leveraging,'' as used by FDA, describes formal or informal 
relationships or agreements with others outside FDA that enhance the 
agency's ability to meet its public health mission. Leveraged 
collaborations between FDA and non-FDA partners, such as industry, 
academia, consumer groups, scientific experts, public health providers, 
states and other Government agencies, are not new to the agency. For 
many years, FDA has used collaborations to accomplish a wide variety of 
tasks related to fulfilling its public health mission. FDA is careful 
to structure its collaborations so that the agency's regulatory 
independence, impartiality, and integrity are preserved. Successful 
collaborations used by FDA and its partners range in size and 
complexity from simple daylong workshops and training sessions to the 
creation of cooperatively administered centers that provide critical 
product-related safety information and expertise, i.e., the National 
Center for Food Safety and Technology, the Joint Initiative for Food 
Safety and Nutrition, and the Product Quality Research Institute. Other 
collaborations involve conducting research to improve the safety, 
efficacy, purity, or potency of regulated products and convening 
experts to evaluate emerging public health issues and to recommend 
actions that should be taken to address the issues.
    This guidance is being issued consistent with FDA's good guidance 
practice regulation (21 CFR 10.115). The guidance document represents 
the agency's current thinking on this topic. 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 requirement of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (see ADDRESSES) written or electronic comments 
regarding the guidance document. Two copies of mailed comments are to 
be submitted, except individuals may submit one copy. Comments should 
be identified with the docket number found in the brackets in the 
heading of this document. A copy of 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.

III. Electronic Access

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

    Dated: February 19, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5793 Filed 3-11-03; 8:45 am]
BILLING CODE 4160-01-S