[Federal Register: November 13, 2001 (Volume 66, Number 219)]
[Notices]
[Page 56831-56832]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no01-77]
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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 The draft guidance document, when finalized, is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draft guidance document enumerates factors that FDA employees should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DATES: Submit written or electronic comments on the draft guidance to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draft guidance document.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]
BILLING CODE 4160-01-S