[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51173-51174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20252]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID: DoD-2013-HA-0175]


Proposed 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 of the Assistant Secretary of Defense for 
Health Affairs announces a proposed public 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;

[[Page 51174]]

(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 October 
21, 2013.

ADDRESSES: You may submit comments, identified by docket number and 
title, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 4800 Mark 
Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
    Instructions: All submissions received must include the agency 
name, docket number and title 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 or 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 the Office of the 
Assistant Secretary of Defense for Health Affairs, Force Health 
Protection and Readiness, ATTN: CAPT John Eckert, 7700 Arlington 
Boulevard, Suite 5101 (CODE: FHP&R), Falls Church, VA 22042-5101, or 
call (703) 681-8356.
    Title; Associated Form; and OMB Number: Researcher Responsibilities 
Form, OMB Number 0720-0042.
    Needs and Uses: The information collection requirement is necessary 
to document researcher's understanding and acceptance of the regulatory 
and ethical responsibilities pertaining to including humans as subjects 
in research. Principal and associate investigators must have the 
proposed, signed form on file before they may engage in research 
conducted or supported by entities under the purview of the Under 
Secretary of Defense for Personnel and Readiness (USD(P&R)).
    Affected Public: Federal Government, for-profit businesses, not-
for-profit businesses.
    Annual Burden Hours: 44.5.
    Number of Respondents: 89.
    Responses per Respondent: 1.
    Average Burden per Response: 30 minutes.
    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 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). DoD guidance requires principal and associate 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 associate investigators engaged in 
research supported or conducted under the purview of the USD(P&R) 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 (32 
CFR part 219) and DoD Instruction 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 renew its Researcher 
Responsibility Form for this purpose and seeks public comment on the 
provisions thereof. Respondents are professionals who have been 
designated as principal or associate investigators. When preparing to 
initiate work on their first human subject research protocol, each 
principal investigator and associate investigator must assure they have 
the proposed Researcher Responsibilities form on file with the 
OUSD(P&R) Component office. This may require new forms from 
approximately 90 investigators. 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 scan 
the form and forward it 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 
OUSD(P&R), 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: August 15, 2013.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2013-20252 Filed 8-19-13; 8:45 am]
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