Meeting of the Secretary's Advisory Committee on Human Research Protections, 10703-10704 [2020-03695]

Download as PDF 10703 Federal Register / Vol. 85, No. 37 / Tuesday, February 25, 2020 / Notices following subjects: (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. Title of the Collection: Federal Evaluation of Making Proud Choices! (MPC!). Type of Collection: Revision. OMB No. 0990–0452. Abstract: The Office of Population Affairs (OPA), U.S. Department of Health and Human Services (HHS) is requesting an extension with revision of a currently approved information collection (OMB No: 0990–0452). The purpose of the revision is to complete the nine-month follow-up data collection for the Federal Evaluation of Making Proud Choices! (MPC). The evaluation is being conducted in 15 schools across four school districts nationwide and will provide information about program design, implementation, and impacts through a rigorous assessment of a highly popular teen pregnancy prevention curriculum—MPC. Clearance is requested for three years. This revision is necessary to complete the 9-month post-baseline follow up data collection after enrolling a fourth and final cohort into the study. The follow-up survey data will be used to determine program effectiveness by comparing sexual behavior outcomes, such as postponing sexual activity, and reducing or preventing sexual risk behaviors and STDs and intermediate outcomes, such as improving exposure, knowledge and attitudes between treatment (program) and control youth. The findings from these analyses of program impacts will be of interest to the general public, to policymakers, and to schools and other organizations interested in supporting a comprehensive approach to teen pregnancy prevention. The revision request also updates the burden by removing the second (15 months post baseline) survey from the data collection. ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents Type of respondent Average burden per response (in hours) Total burden hours Youth participants ............................................................................................ 200 1 30/60 100 Total .......................................................................................................... ........................ 1 ........................ 100 Dated: February 19, 2020. Terry Clark, Asst Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2020–03716 Filed 2–24–20; 8:45 am] BILLING CODE 4150–34–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. ACTION: Notice. AGENCY: 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 Wednesday, March 11, 2020, from 11 a.m. until 4 p.m., and Thursday, March 12, 2020, from 11 a.m. until 4 p.m. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 20:34 Feb 24, 2020 Jkt 250001 (times are tentative and subject to change). The confirmed times and agenda will be posted at https://cmsdrupal-hhs-ohrp-prod.cloud.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html when 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 about one week prior to the meeting at https://cms-drupal-hhsohrp-prod.cloud.hhs.gov/ohrp/sachrpcommittee/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: 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 a.m., on Wednesday, March 11, 2020, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. The meeting will focus on regulatory and ethical issues surrounding Deceased Donor Intervention Research, with a particular focus on recipient informed consent. An additional agenda topic will be a discussion of ethical and regulatory issues surrounding re-consent of subjects for humans subjects research. Other topics will be addressed. For the full meeting agenda, see https://cmsdrupal-hhs-ohrp-prod.cloud.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html The public will have an opportunity to comment to the SACHRP during the meeting’s public comment session or by E:\FR\FM\25FEN1.SGM 25FEN1 10704 Federal Register / Vol. 85, No. 37 / Tuesday, February 25, 2020 / Notices submitting written public comment. Persons who wish to provide public comment should review instructions at https://cms-drupal-hhs-ohrpprod.cloud.hhs.gov/ohrp/sachrpcommittee/meetings/ and respond by midnight Wednesday, March 4, 2020, ET. Individuals submitting written statements as public comment should submit their comments to SACHRP at SACHRP@hhs.gov. Verbal comments will be limited to three minutes each. Time will be allotted for public comment on both days. Note that public comment must be relevant to topics currently being addressed by the SACHRP. Dated: February 6, 2020. Julia G. Gorey, Executive Director, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2020–03695 Filed 2–24–20; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0937–0198] Agency Information Collection Request. 60-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the SUMMARY: following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before April 27, 2020. ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0937–0198– 60D, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, Sherrette.funn@hhs.gov, or call 202–795–7714. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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. Title of the Collection Type of Collection: Public Health Service Polices on Research Misconduct (42 CFR part 93)—OMB No. 0937– 0198—Extension—Office of Research Integrity. Abstract: The Office of Research Integrity is requesting an extension on a currently approved collection. The purpose of the Institutional Assurance and Annual Report on Possible Research Misconduct form PHS–6349 is to provide data on the amount of research misconduct activity occurring in institutions conducting PHS-supported research. The purpose of the Assurance of Compliance by Sub-Award Recipients form PHS–6315 is to establish an assurance of compliance for a subawardee institution. Forms PHS 6349 and PHS–6315 are also used to provide an annual assurance that the institution has established and will follow administrative policies and procedures for responding to allegations of research misconduct that comply with the Public Health Service (PHS) Policies on Research Misconduct (42 CFR part 93). Research misconduct is defined as receipt of an allegation of research misconduct and/or the conduct of an inquiry and/or investigation into such allegations. These data enable the ORI to monitor institutional compliance with the PHS regulation. Need and Proposed Use: The information is needed to fulfill section 493 of the Public Health Service Act (42 U.S.C. 289b), which requires assurances from institutions that apply for financial assistance under the Public Health Service Act for any project or program that involves the conduct of biomedical or behavioral research. In addition, the information is also required to fulfill the assurance and annual reporting requirements of 42 CFR part 93. ORI uses the information to monitor institutional compliance with the regulation. Lastly, the information may be used to respond to congressional requests for information to prevent misuse of Federal funds and to protect the public interest. ESTIMATED ANNUALIZED BURDEN HOUR TABLE PHS–6349 ......................................... PHS–6315 ......................................... Awardee Institutions ......................... Sub-award Institution’s ..................... 5,748 110 1 1 11/60 5/60 1054 9 Total ........................................... ........................................................... ........................ 2 ........................ 1063 [FR Doc. 2020–03717 Filed 2–24–20; 8:45 am] BILLING CODE 4150–31–P jbell on DSKJLSW7X2PROD with NOTICES Average burden per response Respondents (if necessary) Dated: February 19, 2020. Terry Clark, Asst Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. DEPARTMENT OF HEALTH AND HUMAN SERVICES 20:34 Feb 24, 2020 Jkt 250001 Total burden hours Notice and request for comments. Request for extension of approval. ACTION: Indian Health Service Request for Public Comment: 30-Day Information Collection: Indian SelfDetermination and Education Assistance Act Contracts AGENCY: VerDate Sep<11>2014 Number of respondents Number of responses per respondents Forms (if necessary) PO 00000 Indian Health Service, HHS. Frm 00058 Fmt 4703 Sfmt 4703 In compliance with the Paperwork Reduction Act of 1995 (PRA), the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ‘‘Indian Self-Determination and Education Assistance Act Contracts,’’ Office of Management and Budget (OMB) Control Number 0917–0037. IHS SUMMARY: E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10703-10704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03695]


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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.

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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 Wednesday, March 11, 2020, from 11 
a.m. until 4 p.m., and Thursday, March 12, 2020, from 11 a.m. until 4 
p.m. (times are tentative and subject to change). The confirmed times 
and agenda will be posted at https://cms-drupal-hhs-ohrp-prod.cloud.hhs.gov/ohrp/sachrp-committee/meetings/ when 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 about one week prior to the meeting at https://cms-drupal-hhs-ohrp-prod.cloud.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.
    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 a.m., on 
Wednesday, March 11, 2020, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. The 
meeting will focus on regulatory and ethical issues surrounding 
Deceased Donor Intervention Research, with a particular focus on 
recipient informed consent. An additional agenda topic will be a 
discussion of ethical and regulatory issues surrounding re-consent of 
subjects for humans subjects research. Other topics will be addressed. 
For the full meeting agenda, see https://cms-drupal-hhs-ohrp-prod.cloud.hhs.gov/ohrp/sachrp-committee/meetings/
    The public will have an opportunity to comment to the SACHRP during 
the meeting's public comment session or by

[[Page 10704]]

submitting written public comment. Persons who wish to provide public 
comment should review instructions at https://cms-drupal-hhs-ohrp-prod.cloud.hhs.gov/ohrp/sachrp-committee/meetings/ and 
respond by midnight Wednesday, March 4, 2020, ET. Individuals 
submitting written statements as public comment should submit their 
comments to SACHRP at [email protected]. Verbal comments will be limited 
to three minutes each.
    Time will be allotted for public comment on both days. Note that 
public comment must be relevant to topics currently being addressed by 
the SACHRP.

    Dated: February 6, 2020.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2020-03695 Filed 2-24-20; 8:45 am]
 BILLING CODE 4150-36-P
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