Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Substance Use Disorder Treatment and Recovery Loan Repayment Program, OMB No. 0906-xxxx-New, 34454-34456 [2020-12040]
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Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices
Register. FDA considers any comments
received and either publishes final
guidances or publishes revised draft
guidances for comment. Guidances were
last announced in the Federal Register
on March 3, 2020. This notice
announces draft product-specific
guidances, either new or revised, that
are posted on FDA’s website.
II. Drug Products for Which New Draft
Product-Specific Guidances Are
Available
FDA is announcing the availability of
new draft product-specific guidances for
industry for drug products containing
the following active ingredients:
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Active ingredient(s)
Abiraterone acetate.
Amoxicillin.
Aprepitant.
Brexanolone.
Buprenorphine.
Desvenlafaxine.
Dolutegravir sodium; Lamivudine.
Efavirenz; Lamivudine; Tenofovir disoproxil
fumarate.
Estradiol.
Fish oil triglycerides.
Fluorometholone.
Gilteritinib fumarate.
Glycopyrrolate; Indacaterol maleate.
Ivosidenib.
Latanoprost.
Metformin hydrochloride.
Methylphenidate hydrochloride (multiple reference listed drugs).
Metronidazole.
Prucalopride succinate.
Revefenacin.
Sodium zirconium cyclosilicate.
Tafenoquine succinate.
Talazoparib tosylate.
Tretinoin.
Triclabendazole.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Drug Products for Which Revised
Draft Product-Specific Guidances are
Available
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Albendazole.
Azelastine hydrochloride; Fluticasone propionate.
Buprenorphine.
Carglumic acid.
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Health Resources and Services
Administration
Active ingredient(s)
Clindamycin phosphate (multiple referenced
listed drugs).
Clindamycin phosphate; Tretinoin (multiple
referenced listed drugs).
Dapagliflozin.
Dapagliflozin; Saxagliptin hydrochloride.
Desvenlafaxine.
Desvenlafaxine fumarate.
Desvenlafaxine succinate.
Dihydroergotamine mesylate.
Diltiazem hydrochloride (multiple referenced
listed drugs).
Everolimus.
Ferric citrate.
Fluticasone furoate.
Fluticasone propionate.
Fluticasone propionate; Salmeterol xinafoate.
Methylphenidate hydrochloride (multiple referenced listed drugs).
Metoprolol tartrate.
Metronidazole.
Mometasone furoate.
Tretinoin (multiple referenced listed drugs).
Triamcinolone acetonide.
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12100 Filed 6–3–20; 8:45 am]
Active ingredient(s)
VerDate Sep<11>2014
TABLE 2—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND
SPECIFIC GUIDANCES FOR DRUG HUMAN SERVICES
PRODUCTS—Continued
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Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Substance
Use Disorder Treatment and Recovery
Loan Repayment Program, OMB No.
0906—xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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.
DATES: Comments on this ICR should be
received no later than August 3, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Substance Use Disorder Treatment and
Recovery Loan Repayment Program,
OMB No. 0906—xxxx—New.
Abstract: The Further Consolidated
Appropriations Act, 2020 included no
less than $12,000,000 for HRSA’s
Bureau of Health Workforce to establish
the Loan Repayment Program for
Substance Use Disorder (SUD)
Treatment Workforce. This funding will
allow HRSA to provide the repayment
of education loans for individuals
working in either a full-time SUD
treatment job that involves direct
patient care in a Health Professional
Shortage Area (HPSA) designated for
Mental Health or a county where the
SUMMARY:
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Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices
average drug overdose death rate
exceeds the national average.
The program expands the types of
disciplines eligible to include but not
limited to behavioral health
paraprofessionals, occupational
therapists and bachelor trained
counselors. The program also expands
the treatment facilities, to include but
not limited to inpatient psychiatric
facilities, recovery centers, detox
facilities, emergency department and
local community jails and detention
centers. HHS agrees to repay the
qualifying educational loans up to
$250,000.00 in return for 6 years of
service obligation. The forms utilized by
the Substance Use Disorder Treatment
and Recovery (STAR) Loan Repayment
Program (LRP) include the following:
The STAR LRP Application, the
Authorization for Disclosure of Loan
Information form, and the Privacy Act
Release Authorization form, if
applicable. The aforementioned forms
collect information that is needed for
selecting participants and repaying
qualifying educational loans.
Eligible facilities for the STAR LRP
are facilities that provide in-patient and
outpatient, ambulatory, primary and
mental/behavioral health care services
to populations residing in mental health
HPSA or a county where the average
drug overdose death rate exceeds the
national average. The facilities that may
provide related in-patient services may
include, but are not limited to CMSapproved Critical Access Hospitals,
Indian Health Service facilities,
inpatient rehabilitation centers and
psychiatric facilities. HRSA will recruit
facilities for approval. New facilities
must submit an application for review
and approval. The application requests
will contain supporting information on
the clinical service site, recruitment
contact and services provided.
Assistance in completing this
application may be obtained through the
appropriate HRSA personnel. HRSA
will use the information collected on
the applications to determine eligibility
of the facility for the assignment of
health professionals and to verify the
need for clinicians. The STAR LRP
service site approval will undergo a
recertification after no more than 5 years
to ensure SUD services are being
rendered and the desired population is
receiving care.
Despite the similarity in the titles, the
STAR LRP is not the existing NHSC
SUD LRP (OMB #0915–0127), which is
authorized under Title III of the Public
Health Service Act. The STAR LRP is a
newly authorized Title VII program that
has different service requirements, loan
repayment protocols, and authorized
employment facilities.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to obtain
information that is used to assess an
STAR LRP applicant’s eligibility and
qualifications for the program, and to
obtain information for eligible site
applicants. Clinicians interested in
participating in the STAR LRP must
submit an application to the program in
order to participate, and health care
facilities located in any HPSAs with
high overdose rate and MHPSs must
submit a Site Application to determine
the eligibility of sites to participate in
the STAR LRP. The STAR LRP
application asks for personal,
professional and financial information
needed to determine the applicant’s
eligibility to participate in the STAR
LRP. In addition, applicants must
provide information regarding the loans
for which repayment is being requested.
Likely Respondents: Licensed primary
care medical, mental and behavioral
health providers, and other
paraprofessionals who are employed or
seeking employment, and are interested
in serving underserved populations;
health care facilities interested in
participating in the STAR LRP, and
becoming an approved service site;
STAR LRP sites providing behavioral
health care services directly, or through
a formal affiliation with a
comprehensive community-based
primary behavioral health setting,
facility providing comprehensive
behavioral health services, or various
substance abuse treatment facility subtypes.
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
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
STAR LRP Application .........................................................
Authorization for Disclosure of Loan Information Form .......
Privacy Act Release Authorization Form .............................
Site Application ....................................................................
300
300
300
400
1
1
1
1
300
300
300
400
.50
.50
.50
1
150
150
150
400
Total ..............................................................................
1,600
........................
1,600
........................
1000
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Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices
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. 2020–12040 Filed 6–3–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–0361.
Project: National Survey of Substance
Abuse Treatment Services (N–SSATS)
(OMB No. 0930–0106)—Extension
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is requesting an extension of
the National Survey of Substance Abuse
Treatment (N–SSATS) data collection
(OMB No. 0930–0106), which expires
on September 30, 2020. N–SSATS
provides both national and state-level
data on the numbers and types of
patients treated and the characteristics
of facilities providing substance abuse
treatment services. It is conducted
under the authority of Section 505 of the
Public Health Service Act (42 U.S.C.
290aa–4) to meet the specific mandates
for annual information about public and
private substance abuse treatment
providers and the clients they serve.
This request includes:
• Collection of N–SSATS, which is an
annual survey of substance abuse
treatment facilities; and
• Updating of the Inventory of
Behavioral Health Services (I–BHS)
which is the facility universe for the N–
Number of
respondents
Type of respondent and activity
States:
I–BHS Online 1 .....................................................................
Responses
per
respondent
SSATS. I–BHS is also the facility
universe for the annual survey of mental
health treatment facilities, the National
Mental Health Services Survey (N–
MHSS). I–BHS includes all substance
abuse treatment and mental health
treatment facilities known to SAMHSA.
(The N–MHSS data collection is covered
under OMB No. 0930–0119.)
The information in I–BHS and N–
SSATS is needed to assess the nature
and extent of these resources, to identify
gaps in services, and to provide a
database for treatment referrals. Both I–
BHS and N–SSATS are components of
the Behavioral Health Services
Information System (BHSIS).
The request for OMB approval will
include a request to update the I–BHS
facility listing on a continuous basis and
to conduct the N–SSATS and the
between cycle N–SSATS (N–SSATS BC)
in 2021, 2022, and 2023. The N–SSATS
BC is a procedure for collecting services
data from newly identified facilities
between main cycles of the survey and
will be used to improve the listing of
treatment facilities in the online
Behavioral Health Treatment Services
Locator.
Estimated annual burden for the
BHSIS activities is shown below:
Total
responses
Hours per
response
Total burden
hours
56
75
4,200
0.08
336
State Subtotal ...............................................................
Facilities:
I–BHS application 2 ..............................................................
Augmentation screener ........................................................
N–SSATS questionnaire ......................................................
N–SSATS BC .......................................................................
56
........................
4,200
........................
336
800
1,300
17,000
1,000
1
1
1
1
800
1,300
17,000
1,000
0.08
0.08
0.67
0.58
64
104
11,333
580
Facility Subtotal ............................................................
20,100
Total .......................................................................
20,156
20,100
........................
24,300
1 States
12,081
........................
12,417
khammond on DSKJM1Z7X2PROD with NOTICES
use the I–BHS Online system to submit information on newly licensed/approved facilities and on changes in facility name, address,
status, etc.
2 New facilities complete and submit the online I–BHS application form in order to get listed on the Inventory.
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]]>Agencies
[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Pages 34454-34456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Substance
Use Disorder Treatment and Recovery Loan Repayment Program, OMB No.
0906--xxxx--New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 August 3,
2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Substance Use Disorder
Treatment and Recovery Loan Repayment Program, OMB No. 0906--xxxx--New.
Abstract: The Further Consolidated Appropriations Act, 2020
included no less than $12,000,000 for HRSA's Bureau of Health Workforce
to establish the Loan Repayment Program for Substance Use Disorder
(SUD) Treatment Workforce. This funding will allow HRSA to provide the
repayment of education loans for individuals working in either a full-
time SUD treatment job that involves direct patient care in a Health
Professional Shortage Area (HPSA) designated for Mental Health or a
county where the
[[Page 34455]]
average drug overdose death rate exceeds the national average.
The program expands the types of disciplines eligible to include
but not limited to behavioral health paraprofessionals, occupational
therapists and bachelor trained counselors. The program also expands
the treatment facilities, to include but not limited to inpatient
psychiatric facilities, recovery centers, detox facilities, emergency
department and local community jails and detention centers. HHS agrees
to repay the qualifying educational loans up to $250,000.00 in return
for 6 years of service obligation. The forms utilized by the Substance
Use Disorder Treatment and Recovery (STAR) Loan Repayment Program (LRP)
include the following: The STAR LRP Application, the Authorization for
Disclosure of Loan Information form, and the Privacy Act Release
Authorization form, if applicable. The aforementioned forms collect
information that is needed for selecting participants and repaying
qualifying educational loans.
Eligible facilities for the STAR LRP are facilities that provide
in-patient and outpatient, ambulatory, primary and mental/behavioral
health care services to populations residing in mental health HPSA or a
county where the average drug overdose death rate exceeds the national
average. The facilities that may provide related in-patient services
may include, but are not limited to CMS-approved Critical Access
Hospitals, Indian Health Service facilities, inpatient rehabilitation
centers and psychiatric facilities. HRSA will recruit facilities for
approval. New facilities must submit an application for review and
approval. The application requests will contain supporting information
on the clinical service site, recruitment contact and services
provided. Assistance in completing this application may be obtained
through the appropriate HRSA personnel. HRSA will use the information
collected on the applications to determine eligibility of the facility
for the assignment of health professionals and to verify the need for
clinicians. The STAR LRP service site approval will undergo a
recertification after no more than 5 years to ensure SUD services are
being rendered and the desired population is receiving care.
Despite the similarity in the titles, the STAR LRP is not the
existing NHSC SUD LRP (OMB #0915-0127), which is authorized under Title
III of the Public Health Service Act. The STAR LRP is a newly
authorized Title VII program that has different service requirements,
loan repayment protocols, and authorized employment facilities.
Need and Proposed Use of the Information: The need and purpose of
this information collection is to obtain information that is used to
assess an STAR LRP applicant's eligibility and qualifications for the
program, and to obtain information for eligible site applicants.
Clinicians interested in participating in the STAR LRP must submit an
application to the program in order to participate, and health care
facilities located in any HPSAs with high overdose rate and MHPSs must
submit a Site Application to determine the eligibility of sites to
participate in the STAR LRP. The STAR LRP application asks for
personal, professional and financial information needed to determine
the applicant's eligibility to participate in the STAR LRP. In
addition, applicants must provide information regarding the loans for
which repayment is being requested.
Likely Respondents: Licensed primary care medical, mental and
behavioral health providers, and other paraprofessionals who are
employed or seeking employment, and are interested in serving
underserved populations; health care facilities interested in
participating in the STAR LRP, and becoming an approved service site;
STAR LRP sites providing behavioral health care services directly, or
through a formal affiliation with a comprehensive community-based
primary behavioral health setting, facility providing comprehensive
behavioral health services, or various substance abuse treatment
facility sub-types.
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
----------------------------------------------------------------------------------------------------------------
STAR LRP Application............ 300 1 300 .50 150
Authorization for Disclosure of 300 1 300 .50 150
Loan Information Form..........
Privacy Act Release 300 1 300 .50 150
Authorization Form.............
Site Application................ 400 1 400 1 400
-------------------------------------------------------------------------------
Total....................... 1,600 .............. 1,600 .............. 1000
----------------------------------------------------------------------------------------------------------------
[[Page 34456]]
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. 2020-12040 Filed 6-3-20; 8:45 am]
BILLING CODE 4165-15-P
