[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]               
[Page 25685-25686]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-61]                         

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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID: DoD-2008-HA-0046]

 
Proposed New Collection, Comment Request

AGENCY: Office of the Assistant Secretary of Defense for Health 
Affairs, DoD.

ACTION: Notice.

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    In compliance with Section 3506 (c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office the Assistant Secretary of Defense 
for Health Affairs announces a proposed new information collection and 
seeks public comment on the provisions thereof. Comments are invited 
on: (a) Whether the proposed collection of information is necessary for 
the proper performance of the functions of the agency, including 
whether the information shall have practical utility; (b) the accuracy 
of the agency's estimate of the burden of the proposed information 
collection; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; and (d) ways to minimize the burden of 
the information collection on respondents, including through the use of 
automated collection techniques or other forms of information 
technology.

DATES: Consideration will be given to all comments received by July 7, 
2008.

ADDRESSES: You may submit comments, identified by docket number and or 
RIN number and title, by either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, Washington, DC 20301-1160.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
Federal Register document. The general policy for comments and other 
submissions from members of the public is to make these submissions 
available for public viewing on the Internet at http://
www.regulations.gov as they are received without change, including any 
personal identifiers of contact information.

FOR FURTHER INFORMATION CONTACT: To request more information on this 
proposed information collection or to obtain a copy of the proposal and 
associated collection instruments, please write to Office of the 
Assistant Secretary of Defense for Health Affairs, Force Health 
Protection and Readiness, ATTN: Caroline Miner, 5113 Leesburg Pike, 
Suite 901, Falls Church, VA, 22041, or call (703) 575-2677.
    Title; Associated Form; and OMB Number: Researcher Responsibilities 
Form; OMB Number 0720-TBD.
    Needs and Uses: This collection instrument serves to document 
researcher's understanding and acceptance of the regulatory and ethical 
responsibilities for including humans as subjects in research. 
Principal and co-principal investigators must have the proposed, signed 
form on file before they may engage in research conducted, sponsored, 
or supported by entities under the purview of the Under Secretary of 
Defense for Personnel and Readiness.
    Affected Public: Federal government; business or other for-profit; 
not-for-profit institutions.
    Annual Burden Hours: 293.
    Number of Respondents: 585.
    Responses Per Respondent: 1.
    Average Burden Per Response: .50.
    Frequency: On occasion; original document submitted one time per 
researcher. Once their document is on file, a researcher may reaffirm 
their commitment every three years electronically if they remain 
engaged in human subject research.

SUPPLEMENTARY INFORMATION: 

Summary of Information Collection

    Federal Government institutions wishing to conduct, sponsor, or 
support research on human subjects must first submit for approval to 
duly designated authorities an Assurance that they will comply with 
established guidelines in such research. Such Assurances are granted by 
components of DoD and by the Department of Health and Human Services 
(HHS). New DoD guidance now requires principal and co-principal 
investigators individually and explicitly to acknowledge that they 
understand and accept responsibility for protecting the rights and 
welfare of human research subjects. All principal and co-principal 
investigators engaged in research supported or conducted under the 
purview of the Under Secretary of Defense for Personnel and Readiness 
must read and sign a document that attests to their commitment to abide 
by the provisions of: (a) The Belmont Report: Ethical Principles and 
Guidelines for the Protection of Human Subjects of Research; (b) the 
U.S. Department of Defense (DoD) regulations for the protection of 
human subjects at Title 32, Code of Federal Regulations, Part 219 and 
DoD Directive 3216.02; (c) the Assurance of the engaged institution; 
relevant institutional policies and procedures where appropriate; and 
other Federal, State, or local regulations where appropriate. The 
Office of the Assistant Secretary of Defense for Health Affairs 
announces the intent to establish and use a new document format for 
this purpose and seeks public comment on the provisions thereof. 
Respondents are professionals who have been designated as principal or 
co-principal investigators. When preparing to initiate work on their 
first human subject research protocol, each principal investigator and 
co-principal investigators must assure they have the proposed 
Researcher Responsibilities form on file with the Office of the Under

[[Page 25686]]

Secretary of Defense for Personnel and Readiness Component Designated 
Official Office. In the first year this may require new forms from 
approximately 585 investigators, most already doing research. After the 
first year, the burden will level off to approximately 85. The form is 
two pages in length including statements agreed to and half a page for 
respondent signature and contact information. Respondents generally 
will be required to have the signed form scanned and forwarded 
electronically. The form will be filed electronically and form 
completion will be logged into a database. After three years, if a 
researcher still is engaged in research with the Office of the Under 
Secretary of Defense for Personnel and Readiness, he/she will be asked 
to reaffirm his/her commitment electronically. This information 
collection does not involve sensitive personal information and requires 
no special confidentiality measures.

    Dated: May 1, 2008.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense. 1
 [FR Doc. E8-10074 Filed 5-6-08; 8:45 am]

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