Agency Information Collection Request; 60-Day Public Comment Request, 47578-47579 [2024-12111]
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47578
Federal Register / Vol. 89, No. 107 / Monday, June 3, 2024 / Notices
of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding,
Mr. Little is debarred for a period of 5
years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to
section 301(cc) of the FD&C Act, the
importing or offering for import into the
United States of any drug by, with the
assistance of, or at the direction of Mr.
Little is a prohibited act.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12066 Filed 5–31–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0945–0005]
Agency Information Collection
Request; 30-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
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before July 3, 2024.
SUMMARY:
Submit your comments to
Sherrette.Funn@hhs.gov, PRA@hhs.gov,
or by calling (202) 264–0041.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0945–0005 and
project title for reference to Sherrette A.
Funn, the Reports Clearance Officer,
email Sherrette.Funn@hhs.gov, PRA@
hhs.gov, or call (202) 264–0041.
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: HIPAA Audit
Review Survey.
Type of Collection: Reinstatement
with Change of Previously Approved
Collection.
OMB No. 0945–0005: Office for Civil
Rights (OCR)—Health Information
Privacy Division.
Abstract: This information collection
consists of 39 online survey questions
that will be sent to 207 covered entities
and business associates that participated
in the 2016–2017 OCR HIPAA Audits.
ADDRESSES:
The survey will gather information
relating to the effect of the audits on the
audited entities and the entities’
opinions about the audit process.
OCR is conducting a review of the
2016–2017 HIPAA Audits to determine
its efficacy in assessing the HIPAA
compliance efforts of covered entities.
As part of that review, the online
survey will be used to:
• Measure the effect of the 2016–2017
HIPAA Audits on covered entities’ and
business associates’ subsequent actions
to comply with the HIPAA Rules.
• Provide entities with an
opportunity to give feedback on the
Audit and its features, such as the
helpfulness of HHS’ guidance materials
and communications, the utility of the
online submission portal, whether the
Audit helped improve entity
compliance, and the entities’ responses
to the Audit-report findings and
recommendations.
• Provide OCR with information on
the burden imposed on entities to
collect audit-related documents and to
respond to audit-related requests; and
• Seek feedback on the effect of the
HIPAA Audit program on the entities’
day-to-day business operations. The
information, opinions, and comments
collected using the online survey will be
used to improve future OCR HIPAA
Audits.
Type of Respondent: Privacy Officers,
Security Officers, and/or Administrators
of HIPAA covered entities and business
associates.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
Covered Entity Privacy and Security Officer(s) or Administrators ..................
Business Associate Privacy and Security Officer(s) or Administrators ...........
166
41
1
1
45/60
45/60
124.5
30.75
Total ..........................................................................................................
207
........................
........................
155.25
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–12083 Filed 5–31–24; 8:45 am]
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lotter on DSK11XQN23PROD with NOTICES1
Number
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
Agency Information Collection
Request; 60-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
VerDate Sep<11>2014
18:00 May 31, 2024
Jkt 262001
ACTION:
Notice.
FOR FURTHER INFORMATION CONTACT:
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
following summary of a proposed
collection for public comment.
SUMMARY:
Comments on the ICR must be
received on or before August 2, 2024.
DATES:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
ADDRESSES:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
When submitting comments or
requesting information, please include
the document identifier 0990–0260–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03JNN1.SGM
03JNN1
47579
Federal Register / Vol. 89, No. 107 / Monday, June 3, 2024 / Notices
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: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: 3-year extension of
a currently approved collection.
OMB No. 0990–0260
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a
three-year extension of the Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation, OMB
No. 0990–0260.
Information reported to the Federal
departments and agencies under the
Common Rule with respect to a
satisfactory assurance is used to ensure
that an institution engaged in nonexempt research involving human
subjects conducted or supported by a
Common Rule department or agency has
(1) established adequate administrative
policies and procedures for protecting
the rights and welfare of human subjects
in research, and (2) accepts that
responsibility. Other reporting
requirements are used to: assess
whether the institution is following the
established procedures; ensure that
Federal funds are not expended for
unapproved human subjects research;
and, determine if the approved status of
an awarded grant, contract, or
cooperative agreement should be
reviewed, with the ultimate goal of
maintaining or increasing human
subject protections.
Likely Respondents: institutions and
institutional review boards.
Annualized Burden Hour Tables
TABLE 1—ESTIMATED ANNUAL IRB RECORDKEEPING BURDEN
Common rule
provision
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
.115 [Pre-2018 and 2018 Requirement]—Preparation and
documentation of IRB activities ........................................
6,000
16
96,000
12
1,152,000
Total ..............................................................................
........................
........................
96,000
........................
1,152,000
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
respondents
.109(d) [Pre-2018 and 2018 Requirements]—Written notification of ............................................................................
IRB approval or disapproval of research .............................
.116(a) and (b) (Pre-2018 Requirements)/.116 (b), (c) and
(d) [2018 Requirements]—Elements of informed consent
and broad consent ...........................................................
.116(h)—[2018 Requirements]—Posting clinical trial consent form ..........................................................................
.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent ...................................................
.117(c)(2) [Pre-2018 and 2018 Requirements]—Written
statement about the research when informed consent
documentation is waived ..................................................
Total ..............................................................................
Total
annual
disclosures
150,000
0.5
75,000
6,000
25
150,000
0.5
75,000
425
5
2,125
0.5
1,063
6,000
20
120,000
0.5
60,000
6,000
5
30,000
.5
15,000
........................
........................
452,125
........................
308,563
[FR Doc. 2024–12111 Filed 5–31–24; 8:45 am]
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
18:00 May 31, 2024
Jkt 262001
PO 00000
Total hours
25
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Average
burden per
disclosure
6,000
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
BILLING CODE 4150–36–P
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
Frm 00071
Fmt 4703
Sfmt 4703
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines) using
Urine and the laboratories currently
certified to meet the standards of the
Mandatory Guidelines using Oral Fluid.
FOR FURTHER INFORMATION CONTACT:
Anastasia Flanagan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47578-47579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12111]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before August 2,
2024.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 264-0041 and [email protected].
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0260-60D and
project title for reference, to Sherrette A. Funn, email:
[email protected], [email protected] or call (202) 264-0041 the Reports
Clearance Officer.
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
[[Page 47579]]
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: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation.
Type of Collection: 3-year extension of a currently approved
collection.
OMB No. 0990-0260
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting a three-year extension of
the Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation, OMB No. 0990-0260.
Information reported to the Federal departments and agencies under
the Common Rule with respect to a satisfactory assurance is used to
ensure that an institution engaged in non-exempt research involving
human subjects conducted or supported by a Common Rule department or
agency has (1) established adequate administrative policies and
procedures for protecting the rights and welfare of human subjects in
research, and (2) accepts that responsibility. Other reporting
requirements are used to: assess whether the institution is following
the established procedures; ensure that Federal funds are not expended
for unapproved human subjects research; and, determine if the approved
status of an awarded grant, contract, or cooperative agreement should
be reviewed, with the ultimate goal of maintaining or increasing human
subject protections.
Likely Respondents: institutions and institutional review boards.
Annualized Burden Hour Tables
Table 1--Estimated Annual IRB Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
.115 [Pre-2018 and 2018 6,000 16 96,000 12 1,152,000
Requirement]--Preparation and
documentation of IRB activities
-------------------------------------------------------------------------------
Total....................... .............. .............. 96,000 .............. 1,152,000
----------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
.109(d) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Written
notification of................
IRB approval or disapproval of
research.......................
.116(a) and (b) (Pre-2018 6,000 25 150,000 0.5 75,000
Requirements)/.116 (b), (c) and
(d) [2018 Requirements]--
Elements of informed consent
and broad consent..............
.116(h)--[2018 Requirements]-- 425 5 2,125 0.5 1,063
Posting clinical trial consent
form...........................
.117(a) [Pre-2018 and 2018 6,000 20 120,000 0.5 60,000
Requirements]--Documentation of
informed consent...............
.117(c)(2) [Pre-2018 and 2018 6,000 5 30,000 .5 15,000
Requirements]--Written
statement about the research
when informed consent
documentation is waived........
-------------------------------------------------------------------------------
Total....................... .............. .............. 452,125 .............. 308,563
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-12111 Filed 5-31-24; 8:45 am]
BILLING CODE 4150-36-P
