9368 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

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) 

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 

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. 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 

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 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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 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: 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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

(annually) 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Rural Communities Opioid Response Program-Implementation/Neonatal Abstinence Syndrome/MAT Expansion .. 290 2 580 1.24 719.20 

Rural Communities Opioid Response ProgramPsychostimulant Support .................................................. 15 1 15 1.30 19.50 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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, 

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 


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