Agency Information Collection Request; 30-Day Public Comment Request, 67095-67096 [2024-18447]
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Federal Register / Vol. 89, No. 160 / Monday, August 19, 2024 / Notices
Bank (NPDB) self-query results. The
supplemental fee will increase from
$3.00 to $13.00 per mailed paper copy
as these copies will be provided using
U.S. Postal Service certified mail. The
user fees for one-time query,
continuous, and digitally certified selfquery results will remain unchanged.
DATES: The fee increase for mailed paper
self-query results will be effective
October 1, 2024.
FOR FURTHER INFORMATION CONTACT:
David Loewenstein, Director, Division
of Practitioner Data Bank, Bureau of
Health Workforce, HRSA, (301) 443–
2300, NPDBPolicy@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
current fee structure ($2.50/continuous
query enrollment, $2.50/one-time query,
and $3.00/self-query and an additional
$3.00/requested mailed paper copy) was
announced in the Federal Register on
July 21, 2021, (86 FR 38491) and became
effective on October 1, 2021. One-time
queries, continuous query enrollments,
and self-queries are submitted and
query responses are received through
the NPDB’s secure website. Fees are
paid via electronic funds transfer, debit
card, or credit card.
The user fees for one-time query,
continuous, and digitally certified selfquery results will remain unchanged.
Upon requesting a self-query,
practitioners receive a digitally certified
response which they can save and
provide to requesting entities
electronically. Digitally certified selfqueries are delivered in an unalterable
PDF within minutes of the request being
placed. Practitioners can save their
certified response file digitally and
provide it to requesting entities directly.
The security of a digitally certified
response provides assurance that the
response is exactly as it was issued by
the NPDB. However, if needed,
practitioners may also request a mailed
paper copy of their self-query results. To
protect sensitive information in selfquery responses, the mailed results will
now be delivered through U.S. Postal
Service certified mail with receipt
confirmation. Since the NPDB is
required to cover all its costs with user
fees, increased fee for mailed paper selfquery results will offset the certified
mail expense.
HRSA operational standards require
review of NPDB user fees at least every
2 years. The biennial review of NPDB
user fees offers HRSA the opportunity to
evaluate its reserves as well as revenue
relative to costs. Further, the review
provides essential information on
whether the fee rates and authorized
activities are aligned with actual
program costs and activities, and can
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help promote greater understanding of
the fee by NPDB users.
The NPDB is authorized by the Health
Care Quality Improvement Act of 1986
(the Act), Title IV of Public Law 99–660,
as amended (42 U.S.C. 11101 et seq.).
Further, two additional statutes
expanded the scope of the NPDB—
Section 1921 of the Social Security Act,
as amended (42 U.S.C. 1396r–2) and
Section 1128E of the Social Security
Act, as amended (42 U.S.C. 1320a–7e).
Information collected under the Section
1128E authority was consolidated
within the NPDB pursuant to Section
6403 of the Affordable Care Act, Public
Law 111–148; this consolidation became
effective on May 6, 2013. 42 U.S.C.
11137(b)(4), 42 U.S.C. 1396r–2(e), and42
U.S.C. 1320a–7e(d) authorize the
establishment of fees for the costs of
processing requests for disclosure of
such information. Final regulations at45
CFR part 60 set forth the criteria and
procedures for information to be
reported to and disclosed by the NPDB.
In determining any changes in the
amount of user fees, the Department
uses the criteria set forth in section
60.19(b) of the regulations. Section
60.19(b) states:
‘‘The amount of each fee will be
determined based on the following
criteria:
(1) Direct and indirect personnel
costs, including salaries and fringe
benefits such as medical insurance and
retirement,
(2) Physical overhead, consulting, and
other indirect costs (including materials
and supplies, utilities, insurance, travel,
and rent and depreciation on land,
buildings, and equipment),
(3) Agency management and
supervisory costs,
(4) Costs of enforcement, research,
and establishment of regulations and
guidance,
(5) Use of electronic data processing
equipment to collect and maintain
information—the actual cost of the
service, including computer search
time, runs and printouts, and
(6) Any other direct or indirect costs
related to the provision of services.’’
The Department will continue to
review the user fees periodically as
required by Office of Management and
Budget Circular Number A–25 and will
revise fees as necessary. Any future
changes in user fees and their effective
dates will be announced in the Federal
Register.
Carole Johnson,
Administrator.
[FR Doc. 2024–18456 Filed 8–16–24; 8:45 am]
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67095
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
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 September 18,
2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990–0260–30D
and project title for reference.
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: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: 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
SUMMARY:
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67096
Federal Register / Vol. 89, No. 160 / Monday, August 19, 2024 / Notices
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
Number of
respondents
Common rule provision
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 ..............................................................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
Number of
disclosures
per
respondent
Total annual
disclosures
25
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
........................
226,063
[FR Doc. 2024–18447 Filed 8–16–24; 8:45 am]
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[FR Doc. 2024–18489 Filed 8–16–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Library of Medicine; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Library of
Medicine Board of Scientific
Counselors, November 7, 2024, 11:00
a.m. to 2:30 p.m., which was published
in the Federal Register on July 15, 2024,
89 FR 135, Page Number 57422.
This notice is being amended to
announce that the meeting date will be
changed from November 7, 2024, to
November 6, 2024. The meeting will be
virtual.
VerDate Sep<11>2014
18:07 Aug 16, 2024
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National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee on
Research on Women’s Health.
The meeting will be open to the
public as a virtual meeting. Individuals
who plan to view the virtual meeting
and need special assistance or other
reasonable accommodations to view the
meeting, should notify the Contact
PO 00000
Total hours
6,000
Dated: August 13, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Average
burden per
disclosure
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Person listed below in advance of the
meeting. The meeting will be videocast
and can be accessed from the NIH
Videocasting and Podcasting website
(https://videocast.nih.gov/).
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: October 8, 2024.
Time: 9:00 a.m. to 4:30 p.m.
Agenda: ORWH Director’s Report,
Presentation from NIBIB and SEED Office
Directors, Panel discussion on technology,
engineering and, innovation in women’s
health, presentation from the U.S. National
Science Foundation’s Directorate for
Engineering Director, presentations of
concepts for Advisory Committee clearance
including Funding Opportunities to Support
Research on Chronic Female-Specific and
Gynecologic Conditions and Careers of
Women.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Bethesda, MD
20892 (In-Person and Virtual Meeting).
Contact Person: Vivian Ota Wang, Ph.D.,
FACMG, CGC, Deputy Director, Office on
Research for Women’s Health, Division of
Program Coordination, Planning and
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]]>Agencies
[Federal Register Volume 89, Number 160 (Monday, August 19, 2024)]
[Notices]
[Pages 67095-67096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18447]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request; 30-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 September 18,
2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041, or [email protected]. When submitting comments or
requesting information, please include the document identifier 0990-
0260-30D and project title for reference.
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: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation.
Type of Collection: 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
[[Page 67096]]
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
Common rule provision Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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 burden Total hours
respondents per respondent disclosures per 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 .............. 226,063
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-18447 Filed 8-16-24; 8:45 am]
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