57956 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–23767 Filed 9–22–10; 8:45 am] 

BILLING CODE 4150–05–P 

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. 

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://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 selfaddressed 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://

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://

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 

Irene.StithColeman@hhs.gov. 

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 OHRPapproved 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://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] 

BILLING CODE 4150–36–P 


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