Privacy Act of 1974; System of Records

AGENCY:

Defense Health Agency, DoD.

ACTION:

Notice to alter a System of Records.

SUMMARY:

The Defense Health Agency proposes to alter an existing system of records, EDHA 18, entitled “Research Regulatory Oversight Records” in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system provides information to track research protocols to ensure the protection of human and animal subjects in the conduct of DoD-supported research and to ensure that individuals engaged in the performance of DoD-supported research are properly trained and qualified.

DATES:

Comments will be accepted on or before August 14, 2014. This proposed action will be effective on the day following the end of the comment period unless comments are received which result in a contrary determination.

ADDRESSES:

You may submit comments, identified by docket number and title, by any of the following methods:

* Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

* Mail: Federal Docket Management System Office, 4800 Mark Center Drive, East Tower, 2nd Floor, Suite 02G09, Alexandria, VA 22350-3100.

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 or contact information.

FOR FURTHER INFORMATION CONTACT:

Ms. Linda S. Thomas, Chief, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101, or by phone at (703) 681-7500.

SUPPLEMENTARY INFORMATION:

The Defense Health Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at the Defense Privacy and Civil Liberties Office Web site http://dpclo.defense.gov/.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on June 12, 2014, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

EDHA 18

System name:

Research Regulatory Oversight Records (November 18, 2013, 78 FR 69076).

Changes:

System location:

Delete entry and replace with “Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.”

Categories of individuals covered by the system:

Delete entry and replace with “Military, civilian and contractor investigators who engage in or conduct DoD-supported research involving human or animal subjects; and military, civilian or contractor personnel from other Federal agencies, responsible for the review, approval, and regulatory oversight of DoD-supported research involving human or animal subjects.”

Categories of records in the system:

Delete entry and replace with “Name, work and home address; work and personal email; work and personal telephone number, resume, employment information. Documentation of training and certifications required to conduct research involving human or animal subjects or necessary to conduct review, approval, and regulatory oversight of such DoD-supported research.”

Authority for maintenance of the system:

Delete entry and replace with “10 U.S.C. 136, Under Secretary of Defense for Personnel and Readiness; 32 CFR 219, Protection of Human Subjects; DoD Directive 5136.01, Assistant Secretary of Defense for Health Affairs (ASD(HA); DoDI 3216.01, Use of Animals in DoD Programs; and DoDI 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research.”

Purpose(s):

Delete entry and replace with “To collect information on the training and qualifications of those individuals conducting research involving human and/or animal subjects.”

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3)as follows:

To Federal, State, local, or foreign government agencies for identification, tracking and oversight of authorized research procedures and tracking of individual researchers and reviewers involved in the process.

To private business entities for matters relating to eligibility, quality assurance, peer review and program integrity.

The DoD Blanket Routine Uses may apply to this system of records.”

Storage:

Delete entry and replace with “Paper records and/or electronic storage media.”

System Manager(s) and address:

Delete entry and replace with “Program Manager, Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.”

Notification procedure:

Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Program Manager, Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

Requests should contain the name and number of this system of records notice individual's full name, work address, work telephone number and signature.”

Record access procedures:

Delete entry and replace with “Individuals seeking access to information about themselves contained in this system of records should address written inquiries to the Chief, Freedom of Information Act Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

Requests must include the name and the number of this system of record notice, the individual's full name, work address, work telephone number, and signature.”

Contesting record procedures:

Delete entry and replace with “The Office of the Secretary of Defense (OSD) rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81, 32 CFR Part 311, or may be obtained from the system manager.”