[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Page 58261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25202]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Activities Deemed Not To Be Research: Public Health Surveillance,
2018 Requirements
AGENCY: The Office for Human Research Protections, Office of the
Assistant Secretary for Health, Office of the Secretary, HHS.
ACTION: Notice of availability.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
the Assistant Secretary for Health, is announcing the availability of a
draft guidance document entitled, ``Activities Deemed Not to Be
Research: Public Health Surveillance, 2018 Requirements.''
DATES: Submit written comments by December 19, 2018.
ADDRESSES: Submit written requests for a single copy of the draft
guidance document entitled ``Activities Deemed Not to Be Research:
Public Health Surveillance, 2018 Requirements,'' to the Division of
Policy and Assurances, Office for Human Research Protections, 1101
Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 240-453-6909. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft
guidance documents.
You may submit comments identified by docket ID number HHS-OS-OPHS-
2018-0015 (Activities Deemed Not to Be Research: Public Health
Surveillance, 2018 Requirements), by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Enter the docket ID number and click on ``Search.'' On the next page,
click the ``Comment Now'''' action and follow the instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Irene Stith-Coleman, Ph.D., 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, Ph.D., Office for
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852, 240-453-6900; email [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Overview
OHRP, Office of the Assistant Secretary for Health, is announcing
the availability of a draft guidance document entitled ``Activities
Deemed Not to Be Research: Public Health Surveillance, 2018
Requirements.'' This guidance document applies to activities that are
conducted or supported by HHS. It is intended to help entities
determine whether a planned activity constitutes a public health
surveillance activity deemed not to be research under the 2018
Requirements (the revised subpart A of 45 CFR part 46, effective July
19, 2018). The draft guidance document, when finalized, will represent
OHRP's current thinking on this topic. OHRP obtained input from HHS
agencies and the Common Rule departments and agencies in developing the
draft guidance document.
II. Electronic Access
Persons with access may obtain the draft guidance documents on
OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html.
Dated: November 8, 2018.
Julie Kaneshiro,
Deputy Director, Office for Human Research Protections.
[FR Doc. 2018-25202 Filed 11-16-18; 8:45 am]
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