24310 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 

Estimated Total Annual Burden 

Hours: 3,883. 

Authority: 42 U.S.C. 652(a)(7); 42 

U.S.C. 666(c)(1); and 45 CFR 303.7(a)(5). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–08770 Filed 4–22–22; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comprehensive Child Welfare 

Information System (CCWIS) 

Automated Function Checklist and 

Data Quality Plan (OMB #0970–0463) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting a 3-year extension of the 

Comprehensive Child Welfare 

Information System (CCWIS) 

information collection (OMB #0970– 

0463, expiration 8/31/2022). The CCWIS 

information collection includes the 

Automated Function List and the Data 

Quality Plan. There are no required 

instruments associated with the data 

collection and no changes to the data 

collection. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The CCWIS information 

collection includes two components: 

• The Automated Function List 

update required pursuant to section 

1355.52(i)(2); and 

• The Data Quality Plan update 

required pursuant to section 

1355.52(d)(5). 

The CCWIS regulations require 

updates of this information to confirm 

that the project meets CCWIS 

requirements and that project costs are 

appropriately allocated to benefiting 

programs. 

Respondents: Title IV–E agencies 

under the Social Security Act. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Automated Function List section 1355.52(i)(2) ................................................ 55 1 10 550 

Data Quality Plan section 1355.52(d)(5) ......................................................... 55 1 40 2,200 

Estimated Annual Burden Hours: 

2,750. 

Authority: 42 U.S.C. 620 et seq., 42 

U.S.C. 670 et seq., 42 U.S.C. 1301 and 

1302. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–08732 Filed 4–22–22; 8:45 am] 

BILLING CODE 4184–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4206] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

User Fee Small Business Qualification 

and Certification 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 25, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. All 

comments should be identified with the 

OMB control number 0910–0508. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device User Fee Small 

Business Qualification and Certification 

OMB Control Number 0910–0508— 

Extension 

This information collection helps 

support implementation of the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA) (Pub. L. 107–250) 

and FDA’s Medical Device User Fee 

program. Current authorization for 

medical device user fees will be in place 

from October 1, 2017, until September 

30, 2022. 

Section 738(d)(2)(A) and (e)(2)(A) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379j(d)(2)(A) and 

(e)(2)(A)) define a ‘‘small business’’ as 

an entity that reported $100 million or 

less of gross receipts or sales in its most 

recent Federal income tax return, 

including such returns of its affiliates, 

partners, and parent firms. If a firm’s 

gross receipts or sales are no more than 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Notices 24311 

1The guidance ‘‘Medical Device User Fee Small 

Business Qualification and Certification Guidance 

for Industry, Food and Drug Administration Staff 

and Foreign Governments’’ is available at https://

www.fda.gov/regulatory-information/search-fdaguidance-documents/medical-device-user-feesmall-business-qualification-and-certification. 

$30 million (including all affiliates, 

partners, and parent firms), they will 

also qualify for a waiver of the fee for 

their first (ever) premarket application, 

product development protocol, 

biological licensing application, or 

premarket report. A ‘‘small business’’ is 

eligible for reduced or waived fees. If an 

applicant does not provide information 

to FDA demonstrating to FDA’s 

satisfaction that the applicant is a small 

business, the applicant must pay the 

standard (full) fee for any application it 

submits. 

Forms FDA 3602 (‘‘MDUFA Small 

Business Certification Request for a 

Business Headquartered in the United 

States’’) and 3602A (‘‘MDUFA Foreign 

Small Business Certification Request for 

a Business Headquartered Outside the 

United States’’) are submitted to FDA to 

demonstrate that an applicant qualifies 

as a MDUFA small business. The 

guidance ‘‘Medical Device User Fee 

Small Business Qualification and 

Certification; Guidance for Industry, 

Food and Drug Administration Staff and 

Foreign Governments’’ 1 describes the 

process by which a business may 

request certification as a small business 

and the criteria FDA will use to decide 

whether an entity qualifies as a MDUFA 

small business and is eligible for a 

reduction in user fees. 

In the Federal Register of December 

23, 2021 (86 FR 72983), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was 

received, however it did not respond to 

the functional elements solicited in our 

60-day notice or suggest a revision to 

our burden estimate. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

FDA 3602—MDUFA Small Business Certification Request 

For a Business Headquartered in the United States ....... 2,500 1 2,500 1 2,500 

FDA 3602A—MDUFA Foreign Small Business Certification 

Request For a Business Headquartered Outside the 

United States .................................................................... 2,000 1 2,000 1 2,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,500 

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

Our estimated burden is based on the 

number of applications received in the 

last few years and includes the time we 

assume necessary to prepare and submit 

required information. Based on our 

experience with Forms FDA 3602 and 

3602A, we assume it will take 

respondents 1 hour to complete either 

form. We have adjusted our estimated 

‘‘No. of Respondents’’ to better reflect 

recent submission volume. This 

adjustment results in a 2,500-hour 

decrease to the information collection. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08726 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1975–N–0336 (formerly 

1975N–0184)] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Oral 

Prescription Drugs Containing an 

Anticholinergic or Antispasmodic in 

Combination With a Sedative, and 

Single-Entity Antispasmodic Drug 

Products, in Oral Dosage Form; 

Withdrawal of Hearing Requests; Final 

Resolution of Drug Efficacy Study 

Implementation 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that all outstanding hearing 

requests regarding drug products 

containing an anticholinergic or 

antispasmodic in combination with a 

sedative, and single-entity 

antispasmodic drug products, in oral 

dosage form, under Docket FDA–1975– 

N–0336 (formerly 75N–0184) (DESI 

10837) have been withdrawn. Therefore, 

shipment in interstate commerce of any 

such product identified in Docket FDA– 

1975–N–0336 covered by DESI 10837, 

or any identical, related, or similar (IRS) 

product, that is not the subject of an 

approved new drug application (NDA) 

or abbreviated new drug application 

(ANDA) is unlawful as of the date of 

this notice. This notice does not affect 

products covered by DESI 597 under the 

same docket. 

DATES: This notice is applicable April 

25, 2022. 

ADDRESSES: 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 (HFA–305), 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 20852. The 

most relevant background documents 

regarding this matter are available in the 

docket. However, additional background 

documents are available upon request 

(see FOR FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Trunzo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5111, 


khammond on DSKJM1Z7X2PROD with NOTICES