Activities Deemed Not To Be Research: Public Health Surveillance, 2018 Requirements, 58261 [2018-25202]

Download as PDF Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices presentations are permitted. Comments should identify the individual’s name, address, email, telephone number, professional or organization affiliation, background or area of expertise (e.g., parent, family member, researcher, clinician, public health, etc.), and the topic/subject matter. Oral comments must be presented in-person and not via phone/webinar. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify David S. de la Cruz at the address and phone number listed above at least 10 days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 10 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary BILLING CODE 4150–04–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Activities Deemed Not To Be Research: Public Health Surveillance, 2018 Requirements The Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, HHS. ACTION: Notice of availability. AGENCY: 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 ADDRESSES: Submit written requests for a single copy of the draft guidance document entitled ‘‘Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements,’’ to the Division of Policy and Assurances, Office for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 selfaddressed 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 See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance documents.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: https:// 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 DATES: Notice of Interest Rate on Overdue Debts khammond on DSK30JT082PROD with NOTICES [FR Doc. 2018–25204 Filed 11–16–18; 8:45 am] 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.’’ BILLING CODE 4165–15–P Section 30.18 of the Department of Health and Human Services’ claims collection regulations (45 CFR part 30) provides that the Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that the Department of Health and Human Services becomes entitled to recovery. The rate cannot be lower than the Department of Treasury’s current value of funds rate or the applicable rate determined from the ‘‘Schedule of Certified Interest Rates with Range of Maturities’’ unless the Secretary waives interest in whole or part, or a different rate is prescribed by statute, contract, or repayment agreement. The Secretary of the Treasury may revise this rate quarterly. The Department of Health and Human Services publishes this rate in the Federal Register. The current rate of 101⁄8%, as fixed by the Secretary of the Treasury, is certified for the quarter ended September 30, 2018. This rate is based on the Interest Rates for Specific Legislation, ‘‘National 17:20 Nov 16, 2018 Dated: October 10, 2018. David C. Horn, Director, Office of Financial Policy and Reporting. SUMMARY: [FR Doc. 2018–25105 Filed 11–16–18; 8:45 am] VerDate Sep<11>2014 Health Services Corps Scholarship Program (42 U.S.C. 254o(b)(1)(A))’’ and ‘‘National Research Service Award Program (42 U.S.C. 288(c)(4)(B)).’’ This interest rate will be applied to overdue debt until the Department of Health and Human Services publishes a revision. Jkt 247001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 58261 Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to https:// 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 Irene.Stith-Coleman@hhs.gov. 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-forcomments/. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Biodefense Science Board Public Teleconference Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human SUMMARY: E:\FR\FM\19NON1.SGM 19NON1

Agencies

[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: https://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 https://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/.

    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
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