[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Page 57956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23759]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Draft Revision of the Federalwide Assurance
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health, Office for
Human Research Protections.
ACTION: Notice.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
the Assistant Secretary for Health, is announcing the availability of
the draft revised Federalwide Assurance (FWA) form and Terms of
Assurance, and is seeking comment on these draft documents. OHRP is
proposing several changes to simplify and shorten the FWA form and
Terms of Assurance. Institutions engaged in non-exempt human subjects
research conducted or supported by the Department of Health and Human
Services (HHS) must hold an OHRP-approved FWA. The draft revised FWA
form and Terms of Assurance, when finalized, will supersede the current
FWA documents available on the OHRP Web site at
http:[sol][sol]www.hhs.gov/ohrp/assurances/assurances_index.html. OHRP
will consider comments received before implementing any revisions to
the FWA documents.
DATES: Submit written comments by October 25, 2010.
ADDRESSES: Submit written requests for single copies of the draft
revised FWA form and Terms of Assurance to the Division of Policy and
Assurances, Office for Human Research Protections, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft revised FWA
documents.
You may submit comments, identified by docket ID number HHS-OPHS-
2010-0023, by one of the following methods:
Federal eRulemaking Portal:
http:[sol][sol]www.regulations.gov. Enter the above docket ID number in
the ``Enter Keyword or ID'' field and click on ``Search.'' On the next
web page, click on the ``Submit a Comment'' action and follow the
instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Irene Stith-Coleman, PhD, Office for Human Research
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Comments received, including any personal information, will be
posted without change to http:[sol][sol]www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852, 240-453-6900; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
OHRP is announcing the availability of the draft revised FWA form
and Terms of Assurance, and is seeking comment on these draft
documents. Institutions engaged in non-exempt human subjects research
conducted or supported by HHS must hold an OHRP-approved FWA. The draft
revised FWA form and Terms of Assurance, when finalized, will supersede
the current FWA documents available on the OHRP Web site at
http:[sol][sol]www.hhs.gov/ohrp/assurances/assurances_index.html. The
current FWA form has been approved by the Office of Management and
Budget for use through May 31, 2011.
The draft revised FWA form and Terms of Assurance have the
following key changes in comparison to the current FWA documents:
(1) The current separate FWA forms for U.S. and non-U.S.
institutions have been combined into a single form that will still
collect the same basic information previously requested in the current
separate forms, except as noted in items (3) and (4) below.
(2) The Terms of Assurance document has been shortened and
simplified. In the current version, some portions of the text appear
twice; those duplications have been eliminated by re-organizing
portions of the document. In addition, there are several items covered
in the current version that are either not required by the regulations
to be part of an assurance, or which are addressed in the FWA form
itself. These items have been eliminated from the Terms of Assurance
document.
(3) The revised FWA form would replace the current requirement that
all IRBs (both internal and external IRBs) relied upon by the
institution be specifically designated with the requirement that only
internal IRBs be specifically designated or that, if an institution
does not have an internal IRB, only one external IRB be specifically
designated. This change to the FWA form is being proposed in response
to the recommendation from the Secretary's Advisory Committee on Human
Research Protections (SACHRP) that the FWA be modified to remove the
current requirement to designate specific IRBs within the assurance
document itself, replacing this with a commitment by the institution to
rely only on registered IRBs (see SACHRP's July 15, 2009 letter to the
Secretary on the OHRP Web site at http://www.hhs.gov/ohrp/sachrp/documents/20090715LettertoHHSSecretary.pdf).
(4) The revised FWA form would no longer request submission of the
HHS Institution Profile code or the Federal Entity Identification
number.
(5) The revised FWA form would allow the FWA to be signed by the
institution's signatory official electronically and eliminate the need
for submission of a hard-copy signature page by mail or facsimile. Upon
implementation of this change, OHRP intends to require that
institutions submit all FWAs (including new submissions, updates, and
renewals) using the electronic submission system available through the
OHRP Web site at http://ohrp.cit.nih.gov/efile/, unless an institution
lacks the ability to do so electronically. Such electronic submission
currently is required for IRB registration. If an institution believed
it lacked the ability to submit its FWA electronically, it would be
required to contact OHRP by telephone or email and explain why it was
unable to submit its FWA electronically.
(6) The standard period of approval for an FWA would be increased
from the current 3-year period to a 5-year period.
II. Electronic Access
The draft revised FWA form and Terms of Assurance are available on
OHRP's Web site at http://www.hhs.gov/ohrp/requests/.
III. Request for Comments
OHRP requests comments on the draft revised FWA form and Terms of
Assurance. OHRP will consider all comments before implementing any
revisions to the FWA documents.
Dated: September 16, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2010-23759 Filed 9-22-10; 8:45 am]
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