Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Notices 9365 

public/do/PRAViewICR?ref_

nbr=202110-0970-011. Updated 

materials can be found by following the 

directions to submit a comment in the 

ADDRESSES section of this notice. 

Respondents: LIHWAP grant 

recipients. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Quarterly Report for FY 2022 .......................................................................... 157 4 13 8,164 

Quarterly Report for FY 2023 .......................................................................... 157 4 10 6,280 

Annual Report .................................................................................................. 157 2 211 33,127

Household Application ..................................................................................... 1,200,000 1 .5 200,000 

Estimated Total Annual Burden 

Hours: 241,291 (for FY 2022), 239,407 

(for FY 2023). 

Authority: Public Law 116–260 and 

LIHWAP Terms and Conditions Section 

10 (https://www.acf.hhs.gov/sites/ 

default/files/documents/ 

LIHWAP%20Terms%20and%20

Conditions%20for%20States.pdf). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–03610 Filed 2–17–22; 8:45 am] 

BILLING CODE 4184–86–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0893] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Center for Devices 

and Radiological Health Appeals 

Processes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with certain Center 

for Devices and Radiological Health 

(CDRH) appeals processes. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 19, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 19, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 19, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2011–D–0893 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Center 

for Devices and Radiological Health 

Appeals Processes.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 


jspears on DSK121TN23PROD with NOTICES1
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