[Federal Register: February 3, 2006 (Volume 71, Number 23)]
[Notices]
[Page 5861-5862]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe06-76]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0017]
Human Subject Protection--Information for Institutional Review
Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance,
and Development of Food and Drug Administration Guidance Documents;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
initiative, the Information Sheet Guidance Initiative, to update its
process for developing, issuing, and making available guidances
intended for institutional review boards (IRBs), clinical
investigators, and sponsors. Known as ``Information Sheets,'' these
guidances have provided recommendations for IRBs, clinical
investigators, and sponsors to help them fulfill their responsibilities
to protect human subjects who participate in research regulated by FDA
since the early 1980s. The Information Sheet Guidance Initiative is
intended to provide updated information and to issue the Information
Sheets in accordance with FDA's good guidance practices (GGPs). As part
of the initiative, which will be ongoing, the agency plans to rescind
Information Sheets that are obsolete, revise and reissue Information
Sheet Guidances that address current issues, and develop new
Information Sheet Guidances as needed. The agency is also announcing
the availability of five revised Information Sheet Guidances.
DATES: Submit written or electronic comments on the Information Sheet
Guidance Initiative or the Information Sheet Guidances by April 4,
2006. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Copies of the Information Sheets are available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp/guidance.html. Submit written
requests for single copies of the Information Sheet Guidances to the
Office of Training and Communications (HFD-240), Center for Drug
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section of this document for electronic access to the
guidance documents.
FOR FURTHER INFORMATION CONTACT: Bonnie M. Lee, Good Clinical Practice
Program (HF-34), Food and Drug Administration, 5600 Fishers Lane,
Rockville MD 20857, 301-827-3340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the Information Sheet Guidance Initiative, which
will update the current process for developing, issuing, and making
available Information Sheets intended for IRBs, clinical investigators,
and sponsors.
Following issuance of human subject protection regulations by the
Department of Health, Education, and Welfare and FDA in the late 1970s,
IRBs frequently contacted FDA for advice on the best ways to achieve
compliance with the new rules. In response, FDA issued informal
guidance to answer the IRBs' specific questions. In 1984, FDA
consolidated the informal guidance into a series of documents known as
FDA's ``Information Sheets for Institutional Review Boards and Clinical
Investigators.'' These Information Sheets were revised in 1995 and
updated in 1998 to reflect new contact information. They were also
edited to make them user friendly.
The Information Sheets have provided answers to frequently asked
questions about human subject protection, informed consent, review of
research, and related topics. The Information Sheets are intended to
help IRBs, clinical investigators, and sponsors ensure that the rights
and welfare of human research subjects are protected.
In 1997, the Food and Drug Administration Modernization Act
required the agency to codify its GGPs policy. The GGP final rule,
issued in 2000 (Sec. 10.115 (21 CFR 10.115)), requires that the agency
make its guidance development and issuance procedures consistent and
transparent. According to Sec. 10.115, among other things, all FDA
policy documents must be called guidance, and all agency guidance must
be developed and issued according to the requirements in Sec. 10.115.
The Information Sheets are being converted to ``Information Sheet
Guidance'' and are being issued in accordance with GGPs.
[[Page 5862]]
II. Process
The process of rescinding, revising, and reissuing all of the
existing Information Sheets (there are approximately 40) may take
several years to complete. The agency plans to make the process as
transparent as possible. Therefore, FDA advises users to periodically
check the agency's Information Sheet Web page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp/guidance.html
, throughout this time period. As guidances are
revised and reissued and as new guidances are developed, they will be
made available according to the GGP process and on this Web site.
III. Guidances Being Made Available With This Notice
The agency is announcing the availability of the following five
Information Sheet Guidances that have been revised. These five
Information Sheet Guidances replace the Information Sheets of the same
titles (unless otherwise indicated) published in 1998.
``FDA Inspections of Clinical Investigators'' (previously
entitled ``FDA Clinical Investigator Inspections''): This guidance is
intended to provide information about FDA's inspections of clinical
investigators conducted under FDA's Bioresearch Monitoring Program.
``FDA Institutional Review Board Inspections'': This
guidance is intended to provide information about FDA's inspections of
IRBs conducted under FDA's Bioresearch Monitoring Program.
``Waiver of IRB Requirements for Drug and Biologic
Studies'' (previously entitled ``Waiver of IRB Requirements''): This
guidance is intended to provide information about sponsor and sponsor-
investigator requests for waivers of IRB requirements for drug and
biologic studies.
``Significant Risk and Nonsignificant Risk Medical Device
Studies'': This guidance is intended to provide advice to sponsors,
clinical investigators, and IRBs on how to determine the differences
between significant risk and nonsignificant risk medical device
studies.
``Frequently Asked Questions About Medical Devices''
(previously entitled ``Medical Devices; Frequently Asked Questions
about IRB Review of Medical Devices; Emergency Use of Unapproved
Medical Devices''): This guidance is intended to assist sponsors,
clinical investigators, and IRBs by answering common questions FDA
receives concerning medical devices.
These Information Sheet Guidances are level 2 guidances according
to FDA's GGPs regulation. FDA is implementing the guidances immediately
without prior public comment because they contain only minor revisions
to reflect current policy and/or are consistent with policy
interpretations of the Department of Health and Human Service's Office
for Human Research Protections. These Information Sheet Guidances
represent the agency's current thinking on topics concerned with human
subject protection. They do not create or confer any rights for or on
any person and do not operate to bind FDA or the public.
IV. Comments
As with all FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to the Information Sheet
Guidances or suggest topics for new Information Sheet Guidance.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on these Information
Sheet Guidances.
Submit a single copy of electronic comments or two paper copies of
any mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The guidances and received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain the documents at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp/guidance.html.
Dated: January 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1476 Filed 2-2-06; 8:45 am]
BILLING CODE 4160-01-S