Meeting of the Secretary's Advisory Committee on Human Research Protections, 34403-34404 [2019-15289]

Download as PDF 34403 Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Total responses Average burden per response (in hours) Total burden hours NHSC LRP Application ........................................................ Authorization for Disclosure of Loan Information Form ....... Privacy Act Release Authorization Form ............................. Verification of Disadvantaged Background Form ................ Private Practice Option Form .............................................. NHSC Comprehensive Behavioral Health Services Checklist ..................................................................................... NHSC Site Application (including recertification) ................ 9,020 7,150 303 660 330 1 1 1 1 1 9,020 7,150 303 660 330 1.00 .10 .10 .50 .10 9,020.0 715.0 30.3 330.0 33.0 4,400 4,070 1 1 4,400 4,070 .13 .50 572.0 2,035.0 Total .............................................................................. 25,933 ........................ 25,933 ........................ 12,735.3 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–15306 Filed 7–17–19; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. AGENCY: ACTION: Notice. Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. SUMMARY: khammond on DSKBBV9HB2PROD with NOTICES Number of responses per respondent The meeting will be held on Tuesday, July 30, 2019, from 9 a.m. DATES: VerDate Sep<11>2014 17:56 Jul 17, 2019 Jkt 247001 until 4:45 p.m., and Wednesday, July 31, 2019, from 9 a.m. until 3:30 p.m. ADDRESSES: National Institutes of Health, Vaccine Research Center Rooms 1201/1203, 40 Convent Drive, Bethesda, Maryland 20892. FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240–453– 8141; fax: 240–453–6909; email address: SACHRP@hhs.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The Subpart A Subcommittee (SAS) was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment. The Subcommittee on Harmonization (SOH) was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification or coordination. The SACHRP meeting will open to the public at 9 a.m., on Tuesday, July 30, 2019, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 and Dr. Stephen Rosenfeld, SACHRP Chair. New SACHRP members will be welcomed and introduced. The SOH subcommittee will present its recommendations on End User Licensing Agreements and Terms of Service, and Charging Subjects to Participate in Clinical Trials. This will be followed by a discussion of site monitoring under single IRB review, with a review of possible recommendations, and finally a discussion of guidance for institutions affected by the end of the voluntary check-the-box option to extend a federalwide assurance to all research regardless of funding. Wednesday will begin with a discussion of questions newly posed to SACHRP regarding Deceased Organ Intervention Research (DDIR), with a particular focus on recipient informed consent. There will be a panel presentations from leading experts in the field of DDIR, followed by SACHRP discussion. This will be followed by a discussion of ethical and regulatory issues surrounding reconsent of subjects for human subjects research. The meeting is scheduled to end at approximately 3:30 p.m. Time will be allotted for public comment on both days. On-site registration is required for participation in the live public comment session. Note that public comment must be relevant to topics currently being addressed by the SACHRP. Individuals submitting written statements as public comment should email or fax their comments to SACHRP at SACHRP@ hhs.gov at least five business days prior to the meeting. Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special E:\FR\FM\18JYN1.SGM 18JYN1 34404 Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated SACHRP point of contact at the address/phone number listed above at least one week prior to the meeting. Dated: July 3, 2019. Julia G. Gorey, Executive Director, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2019–15289 Filed 7–17–19; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2019–0005; OMB No. 1660–0024] Agency Information Collection Activities: Submission for OMB Review; Comment Request; Federal Assistance for Offsite Radiological Emergency Preparedness and Planning Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. AGENCY: The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use. DATES: Comments must be submitted on or before August 19, 2019. ADDRESSES: Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to dhsdeskofficer@ omb.eop.gov. khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, VerDate Sep<11>2014 17:56 Jul 17, 2019 Jkt 247001 Washington, DC 20472, email address FEMA-Information-CollectionsManagement@fema.dhs.gov, Renae Connell, Emergency Management Specialist, FEMA/NPD/THD, renae.connell@fema.dhs.gov, 202–657– 2294, or Darrell Givens, Emergency Management Specialist, FEMA/NPD/ THD, darrell.givens@fema.dhs.gov, 202– 212–7854. SUPPLEMENTARY INFORMATION: This proposed information collection previously published in the Federal Register on April 24, 2019 at 84 FR 17182 with a 60 day public comment period. No comments were received. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance. Collection of Information Title: Federal Assistance for Offsite Radiological Emergency Preparedness and Planning. Type of Information Collection: Extension, without change, of a currently approved information collection. OMB Number: 1660–0024. Form Titles and Numbers: There are no forms for this collection; rather the regulatory text details the content in which information is transmitted to FEMA. Abstract: The intent of this request is the collection of comments on an extension, without change, of a currently approved information collection an OMB control number representing all information collections related to FEMA Radiological Emergency Preparedness Program requirements described in 44 CFR parts 350 and 352. Affected Public: State, Local or Tribal Government; and business and other for profits. Estimated Number of Respondents: 153. Estimated Number of Responses: 153. Estimated Total Annual Burden Hours: 5,360. Estimated Total Annual Respondent Cost: $311,458. Estimated Respondents’ Operation and Maintenance Costs: $0. Estimated Respondents’ Capital and Start-Up Costs: $0. Estimated Total Annual Cost to the Federal Government: $566,163. Comments Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Maile Arthur, Acting Records Management Branch Chief, Office of the Chief Administrative Officer, Mission Support, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. 2019–15230 Filed 7–17–19; 8:45 am] BILLING CODE 9111–46–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4441– DR; Docket ID FEMA–2019–0001] Arkansas; Amendment No. 4 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice amends the notice of a major disaster declaration for the State of Arkansas (FEMA–4441–DR), dated June 8, 2019, and related determinations. SUMMARY: This amendment was issued July 3, 2019. FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646–2833. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Arkansas is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 8, 2019. DATES: Lincoln County for Individual Assistance (already designated for emergency protective measures [Category B], limited to direct federal assistance under the Public assistance program). E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34403-34404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health.

ACTION: Notice.

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

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's 
Advisory Committee on Human Research Protections (SACHRP) will hold a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP website at: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.

DATES: The meeting will be held on Tuesday, July 30, 2019, from 9 a.m. 
until 4:45 p.m., and Wednesday, July 31, 2019, from 9 a.m. until 3:30 
p.m.

ADDRESSES: National Institutes of Health, Vaccine Research Center Rooms 
1201/1203, 40 Convent Drive, Bethesda, Maryland 20892.

FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, 
SACHRP; U.S. Department of Health and Human Services, 1101 Wootton 
Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141; 
fax: 240-453-6909; email address: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services, through the Assistant Secretary 
for Health, on issues and topics pertaining to or associated with the 
protection of human research subjects.
    The Subpart A Subcommittee (SAS) was established by SACHRP in 
October 2006 and is charged with developing recommendations for 
consideration by SACHRP regarding the application of subpart A of 45 
CFR part 46 in the current research environment.
    The Subcommittee on Harmonization (SOH) was established by SACHRP 
at its July 2009 meeting and charged with identifying and prioritizing 
areas in which regulations and/or guidelines for human subjects 
research adopted by various agencies or offices within HHS would 
benefit from harmonization, consistency, clarity, simplification or 
coordination.
    The SACHRP meeting will open to the public at 9 a.m., on Tuesday, 
July 30, 2019, followed by opening remarks from Dr. Jerry Menikoff, 
Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. New SACHRP 
members will be welcomed and introduced.
    The SOH subcommittee will present its recommendations on End User 
Licensing Agreements and Terms of Service, and Charging Subjects to 
Participate in Clinical Trials. This will be followed by a discussion 
of site monitoring under single IRB review, with a review of possible 
recommendations, and finally a discussion of guidance for institutions 
affected by the end of the voluntary check-the-box option to extend a 
federalwide assurance to all research regardless of funding.
    Wednesday will begin with a discussion of questions newly posed to 
SACHRP regarding Deceased Organ Intervention Research (DDIR), with a 
particular focus on recipient informed consent. There will be a panel 
presentations from leading experts in the field of DDIR, followed by 
SACHRP discussion. This will be followed by a discussion of ethical and 
regulatory issues surrounding reconsent of subjects for human subjects 
research. The meeting is scheduled to end at approximately 3:30 p.m.
    Time will be allotted for public comment on both days. On-site 
registration is required for participation in the live public comment 
session. Note that public comment must be relevant to topics currently 
being addressed by the SACHRP. Individuals submitting written 
statements as public comment should email or fax their comments to 
SACHRP at [email protected] at least five business days prior to the 
meeting.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special

[[Page 34404]]

assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the designated SACHRP point of contact at 
the address/phone number listed above at least one week prior to the 
meeting.

    Dated: July 3, 2019.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2019-15289 Filed 7-17-19; 8:45 am]
BILLING CODE 4150-28-P
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