Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Proposed Collection: Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-0044-Revision, 9368-9369 [2022-03499]
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9368
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPE- thinking of FDA on, among other things,
CIFIC GUIDANCES FOR DRUG PROD- the product-specific design of BE
UCTS
Active ingredient(s)
Aclidinium bromide; Formoterol fumarate.
Apomorphine hydrochloride.
Atropine sulfate.
Brilliant blue G.
Capmatinib hydrochloride.
Cladribine.
Dicyclomine hydrochloride.
Dolutegravir sodium.
Enzalutamide.
Estradiol (multiple referenced listed drugs).
Etelcalcetide.
Flortaucipir F-8.
Fluoroestradiol F-18.
Heparin sodium.
Irinotecan hydrochloride.
Leuprolide acetate (multiple referenced listed
drugs).
Mirabegron.
Nusinersen sodium.
Posaconazole.
Progesterone.
Remdesivir (multiple referenced listed drugs).
Ripretinib.
Selpercatinib.
Selumetinib sulfate.
Sodium chloride.
Vasopressin.
Viloxazine hydrochloride.
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
Active ingredient(s)
jspears on DSK121TN23PROD with NOTICES1
Apixaban.
Clozapine (multiple referenced listed drugs).
Enzalutamide.
Estradiol.
Gefitinib.
Liothyronine sodium.
Methylprednisolone acetate.
Mycophenolate mofetil.
Osimertinib mesylate.
Ruxolitinib phosphate.
Valbenazine tosylate.
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
VerDate Sep<11>2014
18:54 Feb 17, 2022
Jkt 256001
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. Paperwork Reduction Act of 1995
FDA tentatively concludes that these
draft guidances contain no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
V. Electronic Access
Persons with access to the internet
may obtain the draft guidances at
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–03248 Filed 2–17–22; 8:45 am]
BILLING CODE 4164–01–P
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; Proposed Collection: Public
Comment Request; Rural Communities
Opioid Response Program
Performance Measures, OMB No.
0906–0044—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
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 March 21, 2022.
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 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 Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Communities Opioid Response
Program (RCORP) Performance
Measures, OMB No. 0906–0044—
Revision.
Abstract: RCORP is authorized by
Section 711(b)(5) of the Social Security
Act (42 U.S.C. 912(b)(5)) and is a multiinitiative program that aims to: (1)
Support treatment for and prevention of
substance use disorder (SUD), including
opioid use disorder (OUD); and (2)
reduce morbidity and mortality
associated with SUD, to include OUD,
by improving access to and delivering
prevention, treatment, and recovery
support services to high-risk rural
communities. To support this purpose,
RCORP grant initiatives include:
• RCORP-Implementation grants to
fund established networks and consortia
to deliver SUD/OUD prevention,
treatment, and recovery activities in
high-risk rural communities;
• RCORP-Medication Assisted
Treatment Expansion grants to enhance
access to medication-assisted treatment
within eligible hospitals, health clinics,
or tribal organizations in high-risk rural
communities;
• RCORP-Neonatal Abstinence
Syndrome grants to reduce the
incidence and impact of Neonatal
Abstinence Syndrome in rural
communities by improving systems of
care, family supports, and social
determinants of health;
• RCORP-Psychostimulant Support
grants to strengthen and expand
prevention, treatment, and recovery
services for individuals in rural areas
who misuse psychostimulants; to
enhance their ability to access treatment
and move towards recovery; and
ADDRESSES:
E:\FR\FM\18FEN1.SGM
18FEN1
9369
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices
• Note that additional grant programs
may be added pending Fiscal Year 2022
and future Fiscal Year appropriations.
Additionally, all RCORP grant award
recipients are supported by eight
cooperative agreements: RCORPTechnical Assistance, which provides
extensive technical assistance to award
recipients; RCORP-Evaluation, which
evaluates the impact of the RCORP
initiative on rural communities; three
RCORP-Behavioral Health Care
Workforce Centers, which provide
workforce training and education
initiatives in the region served by the
Northern Border Regional Commission;
and three RCORP-Centers of Excellence,
which disseminate best practices related
to the treatment for and prevention of
substance use disorders within rural
communities.
A 60-day notice published in the
Federal Register, 86 FR 69655
(December 8, 2021). There were no
public comments.
Need and Proposed Use of the
Information: Due to the growth in the
number of grant programs included in
the RCORP initiative, as well as
emerging SUD and other behavioral
health trends in rural communities,
HRSA is submitting a revised package
that includes changes to existing RCORP
performance measures as well as new
performance measures that better
demonstrate the impact of the initiative
on rural communities and reduce
burden on the grant recipients.
For this program, performance
measures were developed to provide
data on each RCORP initiative and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy, including: (a) Provision
of, and referral to, rural behavioral
health care services, including SUD
prevention, treatment and recovery
support services; (b) behavioral health
care, including SUD prevention,
treatment, and recovery, process and
outcomes; (c) education of health care
providers and community members; (d)
emerging trends in rural behavioral
health care needs and areas of concern;
and (e) consortium strength and
sustainability. All measures will speak
to the Federal Office of Rural Health
Policy’s progress toward meeting the
goals set.
Likely Respondents: The respondents
will be the grant award recipients of the
RCORP initiatives.
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.
The below burden estimate is
significantly lower than the original
package submitted in 2019 (2,750 total
burden hours). This is likely due to the
fact that (1) many of the grant recipients
HRSA consulted to obtain the burden
estimate for this ICR revision have been
collecting and reporting RCORP
performance measures since March
2020 and have a better understanding of
the burden required; (2) HRSA
eliminated and/or streamlined some of
the more burdensome prevalence and
workforce measures; and (3) grant
recipients of the RCORPPsychostimulant program will only
report on an annual (vs. biannual) basis.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Rural Communities Opioid Response Program-Implementation/Neonatal Abstinence Syndrome/MAT Expansion ..
Rural Communities Opioid Response ProgramPsychostimulant Support ..................................................
jspears on DSK121TN23PROD with NOTICES1
Total ..............................................................................
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. 2022–03499 Filed 2–17–22; 8:45 am]
BILLING CODE 4165–15–P
VerDate Sep<11>2014
18:54 Feb 17, 2022
Jkt 256001
Number of
responses per
respondent
(annually)
580
1.24
719.20
15
1
15
1.30
19.50
305
........................
595
........................
738.70
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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,
Fmt 4703
Total burden
hours
2
National Institutes of Health
Frm 00063
Average
burden per
response
(in hours)
290
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Total
responses
Sfmt 4703
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: Center for Scientific
Review Special Emphasis Panel; RFA–TR–
20–001: Ethical Issues in Translational
Science Research (R01 Clinical Trial
Optional).
Date: March 15, 2022.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9368-9369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03499]
-----------------------------------------------------------------------
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; Proposed Collection:
Public Comment Request; Rural Communities Opioid Response Program
Performance Measures, OMB No. 0906-0044--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 March 21,
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 more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Samantha Miller,
the acting HRSA Information Collection Clearance Officer, at (301) 443-
9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Rural Communities Opioid
Response Program (RCORP) Performance Measures, OMB No. 0906-0044--
Revision.
Abstract: RCORP is authorized by Section 711(b)(5) of the Social
Security Act (42 U.S.C. 912(b)(5)) and is a multi-initiative program
that aims to: (1) Support treatment for and prevention of substance use
disorder (SUD), including opioid use disorder (OUD); and (2) reduce
morbidity and mortality associated with SUD, to include OUD, by
improving access to and delivering prevention, treatment, and recovery
support services to high-risk rural communities. To support this
purpose, RCORP grant initiatives include:
RCORP-Implementation grants to fund established networks
and consortia to deliver SUD/OUD prevention, treatment, and recovery
activities in high-risk rural communities;
RCORP-Medication Assisted Treatment Expansion grants to
enhance access to medication-assisted treatment within eligible
hospitals, health clinics, or tribal organizations in high-risk rural
communities;
RCORP-Neonatal Abstinence Syndrome grants to reduce the
incidence and impact of Neonatal Abstinence Syndrome in rural
communities by improving systems of care, family supports, and social
determinants of health;
RCORP-Psychostimulant Support grants to strengthen and
expand prevention, treatment, and recovery services for individuals in
rural areas who misuse psychostimulants; to enhance their ability to
access treatment and move towards recovery; and
[[Page 9369]]
Note that additional grant programs may be added pending
Fiscal Year 2022 and future Fiscal Year appropriations.
Additionally, all RCORP grant award recipients are supported by
eight cooperative agreements: RCORP-Technical Assistance, which
provides extensive technical assistance to award recipients; RCORP-
Evaluation, which evaluates the impact of the RCORP initiative on rural
communities; three RCORP-Behavioral Health Care Workforce Centers,
which provide workforce training and education initiatives in the
region served by the Northern Border Regional Commission; and three
RCORP-Centers of Excellence, which disseminate best practices related
to the treatment for and prevention of substance use disorders within
rural communities.
A 60-day notice published in the Federal Register, 86 FR 69655
(December 8, 2021). There were no public comments.
Need and Proposed Use of the Information: Due to the growth in the
number of grant programs included in the RCORP initiative, as well as
emerging SUD and other behavioral health trends in rural communities,
HRSA is submitting a revised package that includes changes to existing
RCORP performance measures as well as new performance measures that
better demonstrate the impact of the initiative on rural communities
and reduce burden on the grant recipients.
For this program, performance measures were developed to provide
data on each RCORP initiative and to enable HRSA to provide aggregate
program data required by Congress under the Government Performance and
Results Act of 1993. These measures cover the principal topic areas of
interest to the Federal Office of Rural Health Policy, including: (a)
Provision of, and referral to, rural behavioral health care services,
including SUD prevention, treatment and recovery support services; (b)
behavioral health care, including SUD prevention, treatment, and
recovery, process and outcomes; (c) education of health care providers
and community members; (d) emerging trends in rural behavioral health
care needs and areas of concern; and (e) consortium strength and
sustainability. All measures will speak to the Federal Office of Rural
Health Policy's progress toward meeting the goals set.
Likely Respondents: The respondents will be the grant award
recipients of the RCORP initiatives.
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.
The below burden estimate is significantly lower than the original
package submitted in 2019 (2,750 total burden hours). This is likely
due to the fact that (1) many of the grant recipients HRSA consulted to
obtain the burden estimate for this ICR revision have been collecting
and reporting RCORP performance measures since March 2020 and have a
better understanding of the burden required; (2) HRSA eliminated and/or
streamlined some of the more burdensome prevalence and workforce
measures; and (3) grant recipients of the RCORP-Psychostimulant program
will only report on an annual (vs. biannual) basis.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total Average burden Total burden
Form name respondents respondent responses per response hours
(annually) (in hours)
----------------------------------------------------------------------------------------------------------------
Rural Communities Opioid 290 2 580 1.24 719.20
Response Program-Implementation/
Neonatal Abstinence Syndrome/
MAT Expansion..................
Rural Communities Opioid 15 1 15 1.30 19.50
Response Program-
Psychostimulant Support........
-------------------------------------------------------------------------------
Total....................... 305 .............. 595 .............. 738.70
----------------------------------------------------------------------------------------------------------------
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. 2022-03499 Filed 2-17-22; 8:45 am]
BILLING CODE 4165-15-P
