Federal Register - March 2, 2021
Versione di testo Cosa è?Dateas è un sito indipendente non affiliato a entità governative. La fonte dei documenti PDF che pubblichiamo qui è l'entità governativa indicata in ciascuno di essi. Le versioni in testo sono trascrizioni che realizziamo per facilitare l'accesso e la ricerca di informazioni, ma possono contenere errori o non essere complete.
Source: Federal Register
12194
Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices
and Supporting Regulations; Form Number: CMS372S; and OMB Control Number: 09380272. Through the publication of this document we are withdrawing that notice FR document:
202103916 in its entirety. While the notice published in error, it will be resubmitted for publication and public comment when ready.
Dated: February 25, 2021.
William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
FR Doc. 202104296 Filed 3121; 8:45 am BILLING CODE 412001P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretarys 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 10a of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretarys 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 http
www.dhhs.gov/ohrp/sachrp-committee/
meetings/index.html.
DATES: The meeting will be held on Tuesday, March 23rd, 2021, from 11:00
a.m. until 4:30 p.m., and Wednesday, March 24, 2021, from 11:00 a.m. until 4:30 p.m. times are tentative and subject to change. The confirmed times and agenda will be posted on the SACHRP website 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 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: 240453
8141; fax: 2404536909; email address:
SACHRP@hhs.gov.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:11 Mar 01, 2021
Jkt 253001
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 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 11:00 a.m., on Tuesday, March 23, 2021, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with presentation of recommendations on Justice as an Ethical Concept in 45
CFR 46, followed by an expert panel discussion of draft recommendations on Mandatory Exploratory Biopsies in Research. The day will conclude with discussion of a new SACHRP topic, IRB
Authority to Restrict Use of Data in Research. March 24th will include presentation of Interactions between Sponsors, Clinical Trial Sites, and Research Subjects, and lastly, Consideration of Risks to Bystanders in Research. Other topics may be added;
for the full and updated meeting agenda, see http www.dhhs.gov/ohrp/sachrpcommittee/meetings/index.html.
The public will have an opportunity to send comments to SACHRP during the meetings public comment session or to submit written public comments in advance. Persons who wish to provide public comments should review instructions at https www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html and respond by midnight Wednesday, March 18th, 2021, ET.
Individuals submitting written statements as public comment should submit their comments to SACHRP at SACHRP@hhs.gov. Comments are limited to three minutes each.
Time will be allotted for public comment on both days. Note that public
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
comment must be relevant to topics currently being addressed by SACHRP.
Dated: February 22, 2021.
Julia G. Gorey, Executive Director, SACHRP, Office for Human Research Protections.
FR Doc. 202104244 Filed 3121; 8:45 am BILLING CODE 415036P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health National Institute on Drug Abuse;
Notice of Closed Meetings Pursuant to section 10d 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 552bc4 and 552bc6, 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 on Drug Abuse Special Emphasis Panel; NIDA
L Conflict SEP.
Date: March 25, 2021
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892
Virtual Meeting.
Contact Person: Preethy Nayar, Ph.D.
Scientific Review Officer Scientific Review Branch National Institute on Drug Abuse, NIH 301 North Stonestreet Avenue Bethesda, MD 20892, 3014434577, nayarp2@
csr.nih.gov.
Name of Committee: National Institute on Drug Abuse Special Emphasis Panel;
Implementing the HIV Service Cascade for Justice-Involved Populations U01Clinical Trial Optional.
Date: March 30, 2021.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892, Virtual Meeting.
Contact Person: Sheila Pirooznia, Ph.D.;
Scientific Review Officer, Division of Extramural Review, Scientific Review Branch, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue Bethesda, MD 20892, 301 4969350 sheila.pirooznia@
nih.gov.
E:FRFM02MRN1.SGM
02MRN1