[Federal Register Volume 66, Number 219 (Tuesday, November 13, 2001)]
[Notices]
[Pages 56831-56832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0195]


Draft ``Guidance for FDA Staff: The Leveraging Handbook, An 
Agency Resource for Effective Collaborations;'' 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 draft document entitled ``Guidance for FDA Staff: The 
Leveraging Handbook, An Agency Resource for Effective Collaborations'' 
dated November 2001. The draft guidance document, when finalized, is 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 
draft guidance document enumerates factors that FDA employees should 
consider, and the procedures they should follow, when planning a 
leveraged collaboration.

DATES: Submit written or electronic comments on the draft guidance to

[[Page 56832]]

ensure their adequate consideration in preparation of the final 
document by February 11, 2002. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
FDA: The Leveraging Handbook, An Agency Resource for Effective 
Collaborations'' dated November 2001 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 
document may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800, or by fax by 
calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit written comments on the document 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.

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:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource 
for Effective Collaborations'' dated November 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.
    FDA held two public meetings that were announced in the Federal 
Register to discuss ways in which FDA could improve and increase 
collaborations with outside organizations (65 FR 8365, February 18, 
2000). The meetings were held on March 23, 2000, at Stanford 
University, and on April 12, 2000, at Duke University. More than 300 
people attended the meetings and more than 25 leveraging proposals were 
presented to the agency. FDA is currently reviewing the proposals. To 
review the transcripts of the meetings, you can visit the FDA Dockets 
Management Branch Web site at http://www.fda.gov/ohrms/dockets/dockets/00n0001/00n0001.htm.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). This draft guidance document represents the agency's current 
thinking on the formation and implementation of leveraged 
collaborations between FDA and outside organizations. 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

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written or 
electronic comments regarding this draft guidance document. Submit 
written comments to ensure adequate consideration in preparation of the 
final document by February 11, 2002. Two copies of any 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 document 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 draft guidance 
document at either http://www.fda.gov/oc/leveraging/handbook.html or 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 31, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28386 Filed 11-9-01; 8:45 am]
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