[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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