Meeting of the Secretary's Advisory Committee on Human Research Protections, 48318-48319 [2018-20676]

Download as PDF 48318 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: National Health Service Corps Scholar/ Students to Service Travel Worksheet OMB No. 0915–0278—Extension Abstract: Clinicians participating in the HRSA National Health Service Corps (NHSC) Scholarship Program and the Students to Service (S2S) Loan Repayment Program use the online Travel Request Worksheet to receive travel funds from the Federal Government to visit eligible NHSC sites to which they may be assigned in accordance with the Public Health Service Act (PHSA), section 331(c)(1). The travel approval process is initiated when a NHSC scholar or S2S participant notifies the NHSC of an impending interview at one or more NHSC-approved practice sites. The Travel Request Worksheet is also used to initiate the relocation process after a NHSC scholar or S2S participant has successfully been matched to an approved practice site in accordance with the PHSA, section 331(c)(3). Upon receipt of the Travel Request Worksheet, the NHSC will review and approve or disapprove the request and promptly notify the scholar or S2S participant, and the NHSC logistics contractor regarding travel arrangements and authorization of the funding for the site visit or relocation. Need and Proposed Use of the Information: This information will facilitate NHSC scholar and S2S clinicians’ receipt of federal travel funds that are used to visit high-need NHSC sites. The Travel Request Worksheet is also used to initiate the relocation process after a NHSC scholar or S2S participant has successfully been matched to an approved practice site. Likely Respondents: Clinicians participating in the NHSC Scholarship Program and S2S Loan Repayment Program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel 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 Travel Request Worksheet .................................................. 250 2 500 .0667 33.35 Total .............................................................................. 250 ........................ 500 ........................ 33.35 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. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018–20708 Filed 9–21–18; 8:45 am] BILLING CODE 4165–15–P amozie on DSK3GDR082PROD with NOTICES1 Number of responses per respondent DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Assistant Secretary for Health, Office of the AGENCY: VerDate Sep<11>2014 17:40 Sep 21, 2018 Jkt 244001 Secretary, Department of Health and Human Services. 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/. DATES: The meeting will be held on Tuesday, October 16, 2018, from 8:30 a.m. until 5 p.m., and Wednesday, October 17, 2018, from 8:30 a.m. until 4 p.m. ADDRESSES: 6700B Rockledge Drive, Bethesda, MD 20817. 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, SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 (HHS), 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 E:\FR\FM\24SEN1.SGM 24SEN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices would benefit from harmonization, consistency, clarity, simplification, and/ or coordination. The SACHRP meeting will open to the public at 8:30 a.m., on Tuesday, October 16, 2018, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. The SAS and SOH subcommittees will present their recommendations regarding the description of ‘‘key information,’’ as required by the revised Common Rule at § 46.116(a)(5)(i). This will be followed by a discussion of recommendations of the interpretation of the revised Common Rule’s exemptions § 46.104(d)(1) and (2) for HHS funded research. Lastly, the committee will continue its July discussions on the Office of Inspector General Report, July 7, 2017: ‘‘OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would Strengthen Its Independence.’’ The Wednesday, October 17, meeting will begin at 8:30 a.m. The SAS subcommittee will present and discuss recommendations on the interpretation of ‘‘reasonably available’’ at § 46.408(b), as well as discuss issues surrounding payment of subjects for participation in research. Modifications to the previous day’s work will be discussed and finalized. The meeting will adjourn at approximately 4:00 p.m., October 17, 2018. Time for public comment sessions will be allotted 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 assistance, such as sign language interpretation or other reasonable accommodations, should notify one of the designated SACHRP points of contact at the address/phone number listed above at least one week prior to the meeting. Dated: September 14, 2018. Julia G. Gorey, Executive Director, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2018–20676 Filed 9–21–18; 8:45 am] BILLING CODE 4150–36–P VerDate Sep<11>2014 17:40 Sep 21, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings 48319 Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) Dated: September 18, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–20666 Filed 9–21–18; 8:45 am] BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel; T32 Institutional Training Grants. Date: October 10, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Canopy by Hilton, 940 Rose Avenue, North Bethesda, MD 20852. Contact Person: Nakia C. Brown, Ph.D., Scientific Review Officer, 6701 Democracy Blvd., RM 816, Bethesda, MD 20892, 301– 827–4905, brownnac@mail.nih.gov. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee. Date: October 16–17, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Nakia C. Brown, Ph.D., NIAMS/Scientific Review Officer, 6701 Democracy Blvd., RM 816, Bethesda, MD 20892, 301–827–4905, brownnac@ mail.nih.gov. Name of Committee: National Institute of Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel; AMSC Member Conflict. Date: October 29, 2018. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Democracy One, 6701 Democracy Blvd., Bethesda, MD 20892. Contact Person: Yasuko Furumoto, Ph.D., NIAMS/Scientific Review Officer, 6701 Democracy Blvd., RM 816, Bethesda, MD 20892, 301–451–6520, yasuko.furumoto@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Yogikala Prabhu, Ph.D., 301–761–7789; prabhuyo@niaid.nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: A New Class of Immunomodulatory Drugs for Multiple Sclerosis Description of Technology: Multiple sclerosis (MS) is an autoimmune disease caused by activated autoimmune T lymphocytes in patients resulting in inflammatory demyelination in the central nervous system. Current treatments are focused on functional control of these activated autoimmune T cells, but these treatments are nonspecific T cell inhibitors and have serious, sometimes fatal side effects. A specific therapy aimed at eliminating these autoimmune T cells through restimulation-induced cell death (RICD) could cure the disease and overcome the fatal side effects of current therapies. E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48318-48319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20676]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

ACTION: Notice.

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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, October 16, 2018, from 8:30 
a.m. until 5 p.m., and Wednesday, October 17, 2018, from 8:30 a.m. 
until 4 p.m.

ADDRESSES: 6700B Rockledge Drive, Bethesda, MD 20817.

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 (HHS), 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

[[Page 48319]]

would benefit from harmonization, consistency, clarity, simplification, 
and/or coordination.
    The SACHRP meeting will open to the public at 8:30 a.m., on 
Tuesday, October 16, 2018, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS and SOH subcommittees will present their recommendations 
regarding the description of ``key information,'' as required by the 
revised Common Rule at Sec.  46.116(a)(5)(i). This will be followed by 
a discussion of recommendations of the interpretation of the revised 
Common Rule's exemptions Sec.  46.104(d)(1) and (2) for HHS funded 
research. Lastly, the committee will continue its July discussions on 
the Office of Inspector General Report, July 7, 2017: ``OHRP Generally 
Conducted Its Compliance Activities Independently, But Changes Would 
Strengthen Its Independence.''
    The Wednesday, October 17, meeting will begin at 8:30 a.m. The SAS 
subcommittee will present and discuss recommendations on the 
interpretation of ``reasonably available'' at Sec.  46.408(b), as well 
as discuss issues surrounding payment of subjects for participation in 
research. Modifications to the previous day's work will be discussed 
and finalized. The meeting will adjourn at approximately 4:00 p.m., 
October 17, 2018.
    Time for public comment sessions will be allotted 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 assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify one of the designated SACHRP points of contact at the address/
phone number listed above at least one week prior to the meeting.

    Dated: September 14, 2018.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2018-20676 Filed 9-21-18; 8:45 am]
 BILLING CODE 4150-36-P
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