Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Application for Health Center Program Recipients for Deemed Public Health Service Employment With Liability Protections Under the Federal Tort Claims Act, 0906-0035, Revision, 18373-18374 [2022-06647]
Download as PDF
<![CDATA[
18373
Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices
time required for this task may range
from 5 to 15 minutes; we used the
median, 10 minutes, for the average
burden per disclosure (see table 1).
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1
54.4(b)—Clinical Investigators .............................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section
I
13,082
I
1
Average
burden per
disclosure
Total annual
disclosures
I
13,082
I
0.17
Total hours 2
I
2,224
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
The burden for this information
collection request has changed since the
last OMB approval. Our estimated
burden for the information collection
reflects a 298 hour increase. We have
adjusted our estimated burden for the
information collection to reflect the
number of submissions we received in
the last few years. Additionally, for
products regulated by the Center for
Devices and Radiological Health, we
now include De Novo requests as a type
of application that may rely on clinical
studies. Upon review, we have corrected
an inadvertent omission regarding the
number of BLAs and BLA efficacy
supplements received by our Center for
Drug Evaluation and Research and used,
in part, as a basis for calculating the
cumulative burden estimate. We have
corrected that error here, as reflected in
table 1.
Dated: March 24, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–06661 Filed 3–29–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Application for Health Center
Program Recipients for Deemed Public
Health Service Employment With
Liability Protections Under the Federal
Tort Claims Act, 0906–0035, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
VerDate Sep<11>2014
17:14 Mar 29, 2022
Jkt 256001
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than April 29, 2022.
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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Application for Health Center Program
Recipients for Deemed Public Health
Service Employment with Liability
Protections Under the Federal Tort
Claims Act (FTCA), OMB No. 0906–
0035—Revision.
Abstract: Section 224(g)–(n) of the
Public Health Service (PHS) Act (42
U.S.C. 233(g)–(n)), as amended,
authorizes the ‘‘deeming’’ of entities
receiving funds under section 330 of the
PHS Act as PHS employees for the
purposes of receiving FTCA coverage.
The Health Center Program is
administered by HRSA’s Bureau of
Primary Health Care (BPHC). Health
centers submit deeming applications
annually to BPHC in the prescribed
form and manner in order to obtain
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
deemed PHS employee status for this
purpose.
The FTCA Program has a web-based
application system, the Electronic
Handbooks. These electronic
application forms decrease the time and
effort required to complete the older,
paper-based OMB approved FTCA
application forms. The application
includes: Contact Information; Section
1: Review of Risk Management Systems;
Section 2: Quality Improvement/Quality
Assurance; Section 3: Credentialing and
Privileging; Section 4: Claims
Management; and Section 5: Additional
Information, Certification, and
Signatures.
HRSA is proposing several changes to
the Application for Health Center
Program Award Recipients for Deemed
PHS Employment with Liability
Protections under the FTCA, to be used
for health center deeming applications
for calendar year 2022 and thereafter, to
clarify questions posed and required
documentation. Specifically, the
Application includes the following
proposed changes:
• Updated application language:
Throughout the application, alternate
terminology was utilized to provide
greater clarity and specificity. These
changes were based on stakeholder
feedback and information received from
the HRSA Health Center Program
Support. These changes are not
substantive in nature.
• Some questions were removed from
Quality Improvement/Quality
Assurance Section, as these questions
are similar to information that is also
collected in the Risk Management
Section. This change is intended to
reduce duplicative information
collection.
• For the Credentialing and
Privileging Section, in this cycle, the
application will return to the previous
process of submitting a Credentialing
List with providers’ credentialing and
privileging information.
A 60-day notice published in the
Federal Register, 86 Fed Reg. 72250
(December 21, 2021). There were no
public comments.
E:\FR\FM\30MRN1.SGM
30MRN1
18374
Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices
Need and Proposed Use of the
Information Deeming applications are
required by law and must address
certain specific criteria in order for
deeming determinations to be issued.
The application submissions provide
BPHC with the information essential for
evaluation of compliance with legal
requirements and making a deeming
determination under Section 224(g)–(n)
of the PHS Act (42 U.S.C. 233(g)–(n)).
Likely Respondents: Respondents
include recipients of Health Center
Program funds seeking deemed PHS
employee status under Section 224(g)–
(n) of the PHS Act (42 U.S.C. 233(g)–
(n)).
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.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
FTCA Health Center Program Initial Application .................
FTCA Health Center Program Redeeming Application .......
35
1,125
1
1
35
1,125
2.5
2.5
87.5
2,812.5
Total ..............................................................................
1,160
........................
1,160
........................
2,900
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. 2022–06647 Filed 3–29–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
VerDate Sep<11>2014
17:14 Mar 29, 2022
Jkt 256001
A portion of this meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4) and 552b(c)(6), 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 Advisory
Council on Alcohol Abuse and Alcoholism.
Date: May 10, 2022.
Closed: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Open: 12:45 p.m. to 5:00 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20817.
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National
Advisory Council, Director, Office of
Extramural Activities, National Institute on
Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive,
Room 1458, MSC 6902, Bethesda, MD 20892,
301–443–9737, bautista@mail.nih.gov.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism,
National Cancer Advisory Board, and
National Advisory Council on Drug Abuse.
Date: May 11, 2022.
Open: 11:00 a.m. to 3:00 p.m.
Agenda: Presentation of NIAAA, NCI, and
NIDA Directors’ Update, Scientific Reports,
and other topics within the scope of the
Collaborative Research on Addiction at NIH
(CRAN).
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20817.
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National
Advisory Council, Director, Office of
Extramural Activities, National Institute on
Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive,
Room 1458, MSC 6902, Bethesda, MD 20892,
301–443–9737, bautista@mail.nih.gov.
Paulette S. Gray, Ph.D., Director, Division
of Extramural Activities, National Cancer
Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W444,
Bethesda, MD 20892, 240–276–6340, grayp@
dea.nci.nih.gov.
Susan Weiss, Ph.D., Director, Division of
Extramural Research, National Institute on
Drug Abuse, National Institutes of Health,
6001 Executive Boulevard, NSC, Room 5274,
Bethesda, MD 20892, 301–443–6487, sweiss@
nida.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/Advisory
Council/Pages/default.aspx, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
E:\FR\FM\30MRN1.SGM
30MRN1
]]>Agencies
[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18373-18374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Application for Health
Center Program Recipients for Deemed Public Health Service Employment
With Liability Protections Under the Federal Tort Claims Act, 0906-
0035, Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the 30
day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than April 29,
2022.
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 Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the acting
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Application for Health Center
Program Recipients for Deemed Public Health Service Employment with
Liability Protections Under the Federal Tort Claims Act (FTCA), OMB No.
0906-0035--Revision.
Abstract: Section 224(g)-(n) of the Public Health Service (PHS) Act
(42 U.S.C. 233(g)-(n)), as amended, authorizes the ``deeming'' of
entities receiving funds under section 330 of the PHS Act as PHS
employees for the purposes of receiving FTCA coverage. The Health
Center Program is administered by HRSA's Bureau of Primary Health Care
(BPHC). Health centers submit deeming applications annually to BPHC in
the prescribed form and manner in order to obtain deemed PHS employee
status for this purpose.
The FTCA Program has a web-based application system, the Electronic
Handbooks. These electronic application forms decrease the time and
effort required to complete the older, paper-based OMB approved FTCA
application forms. The application includes: Contact Information;
Section 1: Review of Risk Management Systems; Section 2: Quality
Improvement/Quality Assurance; Section 3: Credentialing and
Privileging; Section 4: Claims Management; and Section 5: Additional
Information, Certification, and Signatures.
HRSA is proposing several changes to the Application for Health
Center Program Award Recipients for Deemed PHS Employment with
Liability Protections under the FTCA, to be used for health center
deeming applications for calendar year 2022 and thereafter, to clarify
questions posed and required documentation. Specifically, the
Application includes the following proposed changes:
Updated application language: Throughout the application,
alternate terminology was utilized to provide greater clarity and
specificity. These changes were based on stakeholder feedback and
information received from the HRSA Health Center Program Support. These
changes are not substantive in nature.
Some questions were removed from Quality Improvement/
Quality Assurance Section, as these questions are similar to
information that is also collected in the Risk Management Section. This
change is intended to reduce duplicative information collection.
For the Credentialing and Privileging Section, in this
cycle, the application will return to the previous process of
submitting a Credentialing List with providers' credentialing and
privileging information.
A 60-day notice published in the Federal Register, 86 Fed Reg.
72250 (December 21, 2021). There were no public comments.
[[Page 18374]]
Need and Proposed Use of the Information Deeming applications are
required by law and must address certain specific criteria in order for
deeming determinations to be issued. The application submissions
provide BPHC with the information essential for evaluation of
compliance with legal requirements and making a deeming determination
under Section 224(g)-(n) of the PHS Act (42 U.S.C. 233(g)-(n)).
Likely Respondents: Respondents include recipients of Health Center
Program funds seeking deemed PHS employee status under Section 224(g)-
(n) of the PHS Act (42 U.S.C. 233(g)-(n)).
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.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
FTCA Health Center Program 35 1 35 2.5 87.5
Initial Application............
FTCA Health Center Program 1,125 1 1,125 2.5 2,812.5
Redeeming Application..........
-------------------------------------------------------------------------------
Total....................... 1,160 .............. 1,160 .............. 2,900
----------------------------------------------------------------------------------------------------------------
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. 2022-06647 Filed 3-29-22; 8:45 am]
BILLING CODE 4165-15-P
