[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18485-18486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8265]
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DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DOD-2010-HA-0042]
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 the following extension of a public
information collection and seeks public comment on the provisions
thereof. Comments are invited on: 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; the accuracy of the agency's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility,
and clarity of the information to be collected; and 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 June 11,
2010.
ADDRESSES: You may submit comments, identified by docket 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 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
[[Page 18486]]
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 0720-0042.
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 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: .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). 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 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 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 Designated Official 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 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 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: April 7, 2010.
Mitchell S. Bryman,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2010-8265 Filed 4-9-10; 8:45 am]
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