Meeting of the Secretary's Advisory Committee on Human Research Protections, 13131-13132 [2023-04324]

Download as PDF 13131 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices lay or licensed clinical patient navigators, who respond to requests for information and support. Program managers and NMDP leadership use this evaluation data to share patients’ experiences as well as make program and resource allocation decisions. Web-based surveys will be administered to all participants (patients, caregivers, and family members) who have contact with the PSC. All participants for whom an email address is known will be invited to complete the survey online. Survey respondents will be notified via email invitation and in the survey instructions that participation is voluntary, and responses will be kept confidential. A follow-up invitation will be sent within 2 weeks to non-respondents. The survey will include these items to measure: (1) their experience, (2) if the contact helped the participant feel more confident in coping with treatment, (3) if the contact helped the participant feel more hopeful, (4) if the contact helped the participant feel less alone, (5) increased awareness of available resources, (6) if the contact helped the participant feel more informed about treatment options, (7) if their questions were answered, and (8) types of challenges faced by participant. The survey data will be analyzed quarterly and annually, and results will be shared with program managers. Feedback indicating a need for improvement will be reviewed by program managers biannually and implementation of resulting program changes or additions will be documented. Likely Respondents: Respondents will include patients, caregivers, and family members who have contact with the PSC via phone or email for HCT navigation services and support (advocacy). The decision to survey all participants was made based on the historically low response rate to this survey due to patients’ frequent transitions in health status as well as transfer between home and the hospital for initial treatment and care for complications. Participants will receive the survey once in a 1-year cycle. If a participant contacts the PSC one or more years after the initial contact, they will receive a second survey. This is because we anticipate that the participants’ needs will likely change during the time lapse. 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 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. The total respondent burden for the customer satisfaction surveys is estimated to be 153 hours. HRSA expects a total of 900 respondents to complete the Be The Match® Patient Support Center Survey. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Total responses Average burden per response (in hours) Total burden hours Be The Match® Patient Support Center Survey .................. 900 1 900 0.17 153 Total .............................................................................. 900 1 900 0.17 153 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, Executive Secretariat. [FR Doc. 2023–04235 Filed 3–1–23; 8:45 am] BILLING CODE 4165–15–P ddrumheller on DSK120RN23PROD 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 18:21 Mar 01, 2023 Jkt 259001 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, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. SUMMARY: The meeting will be held on Wednesday, March 22, 2023 from 11:00 a.m. until 5:00 p.m., and Thursday, March 23, 2023, from 11:00 a.m. until 5:00 p.m. (times are tentative and subject to change). The confirmed times and agenda will be posted on the SACHRP website as this information becomes available. DATES: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 This meeting will be held via webcast. Members of the public may also attend the meeting via webcast. Instructions for attending via webcast will be posted at least one week prior to the meeting at https://www.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html. 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. ADDRESSES: E:\FR\FM\02MRN1.SGM 02MRN1 ddrumheller on DSK120RN23PROD with NOTICES1 13132 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices 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 and/ or coordination. The SACHRP meeting will open to the public at 11:00 a.m., on Wednesday, March 22, 2023, followed by opening remarks from Julie Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with an overview of the recently published GAO report #GAO–23–104721, Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness, followed by a panel of expert speakers addressing the topic of defining stakeholders and evaluating HRPP/IRB quality and effectiveness. SACHRP will subsequently discuss recommendations related to the report’s recommendation #4. A second agenda topic will be introduced and discussed at SACHRP in the afternoon, the FDA draft guidance on Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs. Discussion of both topics will continue on March 23rd. Other topics may be added; for the full and updated meeting agenda, see https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. The meeting will adjourn by 5:00 p.m. March 23, 2022. Time will be allotted for public comment on both days of the meeting. The public may submit written public comment in advance to SACHRP@ hhs.gov no later than midnight March 20th, 2023, ET. Written comments will be shared with SACHRP members and may read aloud during the meeting. Comments which are read aloud are limited to three minutes each. Public comment must be relevant to topics being addressed by the SACHRP. Dated: February 23, 2023. Julia G. Gorey, Executive Director, SACHRP, Office for Human Research Protections. [FR Doc. 2023–04324 Filed 3–1–23; 8:45 am] BILLING CODE 4150–36–P VerDate Sep<11>2014 18:21 Mar 01, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcing Solicitation of Written Comments on the Physical Activity Guidelines Midcourse Report on Older Adults; Correction Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice; correction. AGENCY: The Office of the Assistant Secretary for Health published a document in the Federal Register of February 23, 2023, announcing the solicitation of rritten comments on the Physical Activity Guidelines Midcourse Report on Older Adults. The document announces the availability of the draft Physical Activity Guidelines Midcourse Report on Older Adults (Midcourse Report) and solicits written public comment on the draft report by March 10, 2023. The published Notice did not include the comment deadline. FOR FURTHER INFORMATION CONTACT: Katrina L. Piercy, Ph.D., R.D., Office of Disease Prevention and Health Promotion (ODPHP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); 1101 Wootton Parkway, Suite 420; Rockville, MD 20852; Telephone: 240–453–8271. Email: PAGReviews@hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Correction In the Federal Register of February 24, 2023, in FR Doc. 2023–03859, on page 11922, in the first, second, and third columns, correct the ‘‘[INSERT DATE 2 WEEKS FROM POSTING].’’ bracketed text to read: ‘‘March 10, 2023.’’ Paul Reed, Deputy Assistant Secretary for Health, Office of Disease Prevention and Health Promotion. [FR Doc. 2023–04215 Filed 3–1–23; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice of a hybrid meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/ AIDS (PACHA or the Council) will convene the 76th full council meeting on Wednesday, March 29 and Thursday March 30, 2023. The meeting will convene in Washington, DC and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting inperson. Please email your name to PACHA@hhs.gov by close of business Wednesday, March 22, 2023 to prereigster. There will be a public comment session during the meeting; preregistration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business March 22, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business April 5, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/ federal-response/pacha/about-pacha prior to the meeting. DATES: The meeting will be held on Wednesday, March 29 from approximately 9 a.m.–6 p.m. (ET) and Thursday, March 30 from approximately 9 a.m.–2:30 p.m. (ET). ADDRESSES: The meeting will be located at the Hubert Humphrey building, located at 200 Independence Ave. SW. To attend the meeting virtually, please visit www.hhs.gov/live. FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, MPA, Senior Management Analyst, at PACHA@ hhs.gov or Caroline.Talev@hhs.gov. Additional information can be obtained by accessing the Council’s page on the HIV.gov site at www.hiv.gov/pacha. SUPPLEMENTARY INFORMATION: PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996 and is currently operating under the authority given in Executive Order 14048, dated September 30, 2021. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature. The Council consists of not more than 35 members. Council members are E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13131-13132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04324]


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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.

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

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, the 
full meeting agenda, and instructions for linking to public access will 
be posted on the SACHRP website at https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.

DATES: The meeting will be held on Wednesday, March 22, 2023 from 11:00 
a.m. until 5:00 p.m., and Thursday, March 23, 2023, from 11:00 a.m. 
until 5:00 p.m. (times are tentative and subject to change). The 
confirmed times and agenda will be posted on the SACHRP website as this 
information becomes available.

ADDRESSES: This meeting will be held via webcast. Members of the public 
may also attend the meeting via webcast. Instructions for attending via 
webcast will be posted at least one week prior to the meeting at 
https://www.hhs.gov/ohrp/sachrp-committee/meetings/.

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.

[[Page 13132]]

    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 and/or 
coordination. The SACHRP meeting will open to the public at 11:00 a.m., 
on Wednesday, March 22, 2023, followed by opening remarks from Julie 
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP 
Chair. The meeting will begin with an overview of the recently 
published GAO report #GAO-23-104721, Institutional Review Boards: 
Actions Needed to Improve Federal Oversight and Examine Effectiveness, 
followed by a panel of expert speakers addressing the topic of defining 
stakeholders and evaluating HRPP/IRB quality and effectiveness. SACHRP 
will subsequently discuss recommendations related to the report's 
recommendation #4.
    A second agenda topic will be introduced and discussed at SACHRP in 
the afternoon, the FDA draft guidance on Ethical Considerations for 
Clinical Investigations of Medical Products Involving Children Guidance 
for Industry, Sponsors, and IRBs.
    Discussion of both topics will continue on March 23rd. Other topics 
may be added; for the full and updated meeting agenda, see https://www.dhhs.gov/ohrp/sachrp-committee/meetings/. The meeting 
will adjourn by 5:00 p.m. March 23, 2022.
    Time will be allotted for public comment on both days of the 
meeting. The public may submit written public comment in advance to 
[email protected] no later than midnight March 20th, 2023, ET. Written 
comments will be shared with SACHRP members and may read aloud during 
the meeting. Comments which are read aloud are limited to three minutes 
each. Public comment must be relevant to topics being addressed by the 
SACHRP.

    Dated: February 23, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2023-04324 Filed 3-1-23; 8:45 am]
BILLING CODE 4150-36-P
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