9366 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Center for Devices and Radiological 

Health Appeals Processes 

OMB Control Number 0910–0738— 

Extension 

This information collection supports 

implementation of recommendations 

found in FDA guidance. As discussed in 

the document entitled ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; Center for Devices 

and Radiological Health (CDRH) 

Appeals Processes’’ (July 2019), there 

are various processes by which appeals 

requests regarding review of decisions 

or actions by CDRH may be submitted 

to the Agency. The guidance is available 

for download from our website at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses. The guidance document 

provides general format and content 

recommendations in this regard, 

discusses applicable regulations with 

regard to the timing of such 

submissions, and describes the 

collection of information not expressly 

specified under existing regulations 

such as the submission of the request for 

review, minor clarifications as part of 

the request, and supporting information. 

While CDRH already possesses in the 

administrative file the information that 

would form the basis of a decision on 

a matter under appeal, the submission 

of information as recommended in the 

guidance regarding the appeal request 

itself, as well as data and information 

relied on by the requestor in the appeal, 

will help facilitate timely resolution of 

the decision under review. We are 

accounting for burden respondents may 

incur as a result of these Agency 

recommendations in this collection 

request. Additional information about 

the CDRH appeals process is described 

in the companion guidance entitled 

‘‘Center for Devices and Radiological 

Health (CDRH) Appeals Processes: 

Questions and Answers About 517A— 

Guidance for Industry and Food and 

Drug Administration Staff’’ (March 

2020), also available for download from 

our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/center-devicesand-radiological-health-cdrh-appealsprocesses-questions-and-answers-about517a. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

CDRH Appeals Processes: Guidance for Industry and 

FDA Staff 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Recommended format and content elements ..................... 35 1 35 8 280 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate 35 requests will be 

submitted annually to review decisions 

and actions by CDRH employees, we 

attribute one respondent per 

submission, and we assume each 

request will take 8 hours to prepare. 

Based on our evaluation of the 

information collection since last OMB 

approval, we have made no adjustments 

to the currently approved burden 

estimate. 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03546 Filed 2–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 9367 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 19, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific guidances and provide a 

meaningful opportunity for the public to 

consider and comment on those 

guidances. Under that process, draft 

guidances are posted on FDA’s website 

and announced periodically in the 

Federal Register. The public is 

encouraged to submit comments on 

those recommendations within 60 days 

of their announcement in the Federal 

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 November 9, 2021 (86 FR 62182). 

This notice announces draft productspecific 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: 


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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