[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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draft guidance document entitled, ``Activities Deemed Not to Be 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ADDRESSES: Submit written requests for a single copy of the draft 
guidance document entitled ``Activities Deemed Not to Be Research: 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INFORMATION section for information on electronic access to the draft 
guidance documents.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]
BILLING CODE 4150-36-P