Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: DATA 2000 Waiver Training Payment Program Application for Payment, OMB No. 0906-0061, 84149-84150 [2023-26554]
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84149
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices
orphan@fda.hhs.gov; or by mailing the
required information to the OOPD at the
address found on our website. New
users of the CDER NextGen Portal must
register for an account. For designation
requests submitted by email, the Agency
recommends using automated read
receipt to verify receipt of the email.
Sponsors and others who plan to
email information to FDA that is
private, sensitive, proprietary, or
commercial confidential are strongly
encouraged to send it from an FDAsecured email address so the
transmission is encrypted. The Agency
will assume the addresses of emails
received or email addresses provided as
a point of contact are secure when
responding to those email addresses.
Sponsors and others can establish a
secure email address link to FDA by
sending a request to SecureEmail@
fda.hhs.gov. There may be a fee to a
commercial enterprise for establishing a
digital certificate before encrypted
emails can be sent to FDA.
Respondents to the information
collection are sponsors who develop
investigational drugs and biologicals for
commercial use and who seek orphan
drug designation, and upon approval or
licensure, orphan drug exclusivity.
In the Federal Register of June 13,
2023 (88 FR 38513), we published a 60day notice soliciting comment on the
proposed collection of information.
Although we received one comment, it
was not responsive to the information
collection topics solicited and therefore
is not addressed in this notice.
We estimate the burden of this
collection of information as follows
based on data from 2022:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Part 316 associated records ................................................
§§ 316.20, 316.21, 316.26 (Form FDA 4035) ......................
§ 316.22; Notifications of changes in agents .......................
§ 316.24(a); Deficiency letters and granting orphan-drug
designation .......................................................................
§ 316.27; Submissions to change ownership of orphandrug designation ...............................................................
§ 316.30; Annual reports ......................................................
§ 316.36; Assurance of the availability of sufficient quantities of the orphan drug; holder’s consent for the approval of other marketing applications for the same drug
Guidance Recommendations: Meeting requests to OOPD
and related submission packages ....................................
Total ..............................................................................
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
Number of
records per
recordkeeper
Number of
respondents
21 CFR part or section; activity
Total
annual
records
Average
burden
per record
Total
hours
780
780
300
1.25
1.25
1
975
975
300
135
32
0.5
131,625
31,200
150
20
1
20
2
40
90
2,039
1
1
90
2,039
3
3
270
6,117
1
3
3
15
45
807
1.5
1,211
4
4,842
........................
........................
5,613
........................
174,289
are no capital costs or operating and maintenance costs associated with this collection of information.
Our burden estimate includes those
activities related to: (1) requesting
orphan drug designation; (2) responding
to deficiencies letters with submissions
of amendments; (3) keeping files current
with contact information for agents and
transfer of ownership, when applicable;
(4) submitting annual reports while
products have designation status; and
(5) requesting and preparing for both
informal and formal meetings. Because
the PRA defines a recordkeeping
requirement to include reporting those
records to the Federal government, we
account for these activities cumulatively
in table 1 above. Upon a recent
evaluation of the information collection,
we adjusted our burden estimate to
reflect an overall increase of 50,616
hours and an increase of 766 records
annually. We attribute this adjustment
to an increase in the number of
submissions, amendments, and annual
reports.
Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26544 Filed 12–1–23; 8:45 am]
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19:20 Dec 01, 2023
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: DATA 2000
Waiver Training Payment Program
Application for Payment, OMB No.
0906–0061
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Comments on this ICR should be
received no later than February 2, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
DATA 2000 Waiver Training Payment
Program Application for Payment, OMB
No. 0906–0061—Revision.
Abstract: The Substance Use—
Disorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities (SUPPORT)
Act (Pub. L. 115–271), section 6083,
amended the Social Security Act
(subsections 1834(o)(3) and 1833(bb)),
DATES:
E:\FR\FM\04DEN1.SGM
04DEN1
84150
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices
authorizing the HHS Secretary to pay
Federally Qualified Health Centers
(FQHCs) and Rural Health Clinics
(RHCs) for the average cost of training
for purposes of receiving a DATA 2000
waiver for their physicians and
practitioners to furnish opioid use
disorder treatment services. The
SUPPORT Act made $6 million
available to FQHCs and $2 million
available to RHCs under the DATA 2000
Waiver Training Payment Program. To
receive payment, FQHCs and RHCs
must submit an application in the
manner specified by the Secretary.
Authority to administer the DATA 2000
program has been delegated to HRSA.
Further information about the program
can be found in the link below which
provides guidance on the requirements
of the DATA 2000 program and how
qualified FQHCs and RHCs can apply to
the program: https://help.hrsa.gov/
display/public/EHBSKBFG/
DATA+2000+Waiver+Training
+Payment+Program+FAQs.
This purpose of this revision is to
update the burden estimate for the RHC
application process because the funding
appropriated for FQHC DATA 2000
payments has been fully expended.
Therefore, no new applications for
FQHC DATA 2000 payments can be
accepted or approved. Only Medicare
participating RHCs can apply for
payments through the DATA 2000
program, and pursuant to the
authorizing statute and subsequent
legislation eliminating the DATA 2000
waiver requirement, such RHCs may
only receive payments with respect to
providers who first received their DATA
2000 Waiver between January 1, 2019,
and December 29, 2022.
Applicant entities must provide
information identifying the submitting
organization and the number of
practitioners who have completed
training and obtained a DATA 2000
waiver. The form will also require the
entity to include information regarding
each claimed practitioner’s name,
practitioner type (e.g., physician,
physician assistant, nurse practitioner,
certified nurse midwife, clinical nurse
specialist, certified registered nurse, or
anesthetist), National Provider Identifier
number, Drug Enforcement
Administration number, state license
number, length of training, date the
training was completed, date of waiver
attainment, and DATA 2000 waiver
number. Additionally, the form will
require signature of an attestation
statement certifying that: (1) each
practitioner for which the entity is
seeking payment under the application
is employed by or working under
contract for the applicant health facility;
(2) it is the first time the entity is
seeking payment on behalf of the listed
practitioner(s); (3) the entity is eligible
to seek payment under 42 U.S.C.
1395m(o)(3) or 42 U.S.C. 1395l(bb); (4)
each practitioner is furnishing opioid
use disorder treatment services; and (5)
the statements herein are true, complete,
and accurate to the best of the
applicant’s knowledge.
Need and Proposed Use of the
Information: The Substance Use—
Disorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities Act requires
RHCs to submit to the Secretary an
application for payment at such time, in
such manner, and containing such
information as specified by the
Secretary in order to receive a payment
under section 6083. This form will
allow RHCs to apply for such payments
based on the average cost of training to
obtain DATA 2000 waivers, as
determined by the Secretary, for their
physicians and practitioners to furnish
opioid use disorder treatment services.
The form will also provide HRSA with
the requisite data to validate qualifying
DATA 2000 waiver possessions for the
purpose of ensuring accurate payments
to RHCs.
Likely Respondents: Only Medicare
participating RHCs are eligible to apply.
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
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
DATA 2000 Waiver Training Payment Program Application for Payment ...........
300
1
300
0.5
150.0
Total ...............................................................................................................
300
1
300
........................
150.0
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
VerDate Sep<11>2014
19:20 Dec 01, 2023
Jkt 262001
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
Indian Health Service
[FR Doc. 2023–26554 Filed 12–1–23; 8:45 am]
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PO 00000
National Urban Indian Behavioral
Health Awareness
Announcement Type: New.
Funding Announcement Number:
HHS–2024–IHS–NUIBH–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.654.
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]]>Agencies
[Federal Register Volume 88, Number 231 (Monday, December 4, 2023)]
[Notices]
[Pages 84149-84150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26554]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: DATA 2000
Waiver Training Payment Program Application for Payment, OMB No. 0906-
0061
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than February
2, 2024.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: DATA 2000 Waiver Training
Payment Program Application for Payment, OMB No. 0906-0061--Revision.
Abstract: The Substance Use--Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities (SUPPORT)
Act (Pub. L. 115-271), section 6083, amended the Social Security Act
(subsections 1834(o)(3) and 1833(bb)),
[[Page 84150]]
authorizing the HHS Secretary to pay Federally Qualified Health Centers
(FQHCs) and Rural Health Clinics (RHCs) for the average cost of
training for purposes of receiving a DATA 2000 waiver for their
physicians and practitioners to furnish opioid use disorder treatment
services. The SUPPORT Act made $6 million available to FQHCs and $2
million available to RHCs under the DATA 2000 Waiver Training Payment
Program. To receive payment, FQHCs and RHCs must submit an application
in the manner specified by the Secretary. Authority to administer the
DATA 2000 program has been delegated to HRSA. Further information about
the program can be found in the link below which provides guidance on
the requirements of the DATA 2000 program and how qualified FQHCs and
RHCs can apply to the program: https://help.hrsa.gov/display/public/EHBSKBFG/DATA+2000+Waiver+Training+Payment+Program+FAQs.
This purpose of this revision is to update the burden estimate for
the RHC application process because the funding appropriated for FQHC
DATA 2000 payments has been fully expended. Therefore, no new
applications for FQHC DATA 2000 payments can be accepted or approved.
Only Medicare participating RHCs can apply for payments through the
DATA 2000 program, and pursuant to the authorizing statute and
subsequent legislation eliminating the DATA 2000 waiver requirement,
such RHCs may only receive payments with respect to providers who first
received their DATA 2000 Waiver between January 1, 2019, and December
29, 2022.
Applicant entities must provide information identifying the
submitting organization and the number of practitioners who have
completed training and obtained a DATA 2000 waiver. The form will also
require the entity to include information regarding each claimed
practitioner's name, practitioner type (e.g., physician, physician
assistant, nurse practitioner, certified nurse midwife, clinical nurse
specialist, certified registered nurse, or anesthetist), National
Provider Identifier number, Drug Enforcement Administration number,
state license number, length of training, date the training was
completed, date of waiver attainment, and DATA 2000 waiver number.
Additionally, the form will require signature of an attestation
statement certifying that: (1) each practitioner for which the entity
is seeking payment under the application is employed by or working
under contract for the applicant health facility; (2) it is the first
time the entity is seeking payment on behalf of the listed
practitioner(s); (3) the entity is eligible to seek payment under 42
U.S.C. 1395m(o)(3) or 42 U.S.C. 1395l(bb); (4) each practitioner is
furnishing opioid use disorder treatment services; and (5) the
statements herein are true, complete, and accurate to the best of the
applicant's knowledge.
Need and Proposed Use of the Information: The Substance Use--
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act requires RHCs to submit to the Secretary
an application for payment at such time, in such manner, and containing
such information as specified by the Secretary in order to receive a
payment under section 6083. This form will allow RHCs to apply for such
payments based on the average cost of training to obtain DATA 2000
waivers, as determined by the Secretary, for their physicians and
practitioners to furnish opioid use disorder treatment services. The
form will also provide HRSA with the requisite data to validate
qualifying DATA 2000 waiver possessions for the purpose of ensuring
accurate payments to RHCs.
Likely Respondents: Only Medicare participating RHCs are eligible
to apply.
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
----------------------------------------------------------------------------------------------------------------
DATA 2000 Waiver Training 300 1 300 0.5 150.0
Payment Program Application for
Payment........................
-------------------------------------------------------------------------------
Total....................... 300 1 300 .............. 150.0
----------------------------------------------------------------------------------------------------------------
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. 2023-26554 Filed 12-1-23; 8:45 am]
BILLING CODE 4165-15-P
