30956 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

agencies to have a more customercentric focus. Because of this, GSA 

anticipates an increase in requests to 

use this generic clearance, as the plan 

states that: A customer-centric principle 

charges us to do several things: conduct 

research to understand the customer’s 

business, needs and desires; ‘‘make 

content more broadly available and 

accessible and present it through 

multiple channels in a program-and 

device-agnostic way; make content more 

accurate and understandable by 

maintaining plain language and content 

freshness standards; and offer easy 

paths for feedback to ensure we 

continually improve service delivery. 

The customer-centric principle holds 

true whether our customers are internal 

(e.g., the civilian and military federal 

workforce in both classified and 

unclassified environments) or external 

(e.g., individual citizens, businesses, 

research organizations, and state, local, 

and tribal governments).’’ 

B. Annual Reporting Burden 

Respondents: 500,000. 

Responses per Respondent: 1. 

Total Annual Responses: 500,000. 

Hours per Response: 60.446 minutes. 

Total Burden Hours: 32,970.72. 

C. Public Comments 

A 60-day notice published in the 

Federal Register at 87 FR 14532 on 

March 15, 2022. No comments were 

received. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the GSA Regulatory Secretariat Division, 

by calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 3090–0297, Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery, in all correspondence. 

Beth Anne Killoran, 

Deputy Chief Information Officer. 

[FR Doc. 2022–10896 Filed 5–19–22; 8:45 am] 

BILLING CODE 6820–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; State 

Access and Visitation Grant 

Application (OMB #0970–0482) 

AGENCY: Office of Child Support 

Enforcement (OCSE), Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The federal Office of Child 

Support Enforcement (OCSE), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS) is 

requesting a 3-year extension of the 

State Access and Visitation Grant 

Application (OMB #0970–0482, 

expiration 5/31/2022. There are changes 

requested to the form. 

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 Personal 

Responsibility and Work Opportunity 

Reconciliation Act of 1996 created the 

‘‘Grants to States for Access and 

Visitation’’ program (AV grant program). 

Funding for the program began in fiscal 

year 1997 with a capped, annual 

entitlement of $10 million. The 

statutory goal of the program is to 

provide funds to states that will enable 

them to provide services for the purpose 

of increasing noncustodial parent access 

to and visitation with their children. 

State governors decide which state 

entity will be responsible for 

implementing the AV grant program in 

addition to determining who will be 

served, what services will be provided, 

and whether the services will be 

statewide or in local jurisdictions. The 

statute specifies certain activities which 

may be funded, including voluntary and 

mandatory mediation, counseling, 

education, the development of parenting 

plans, supervised visitation, and the 

development of guidelines for visitation 

and alternative custody arrangements. 

Even though OCSE manages this 

program, funding for the AV grant is 

separate from funding for federal and 

state administration of the Child 

Support program. 

Section 469B(e)(3) of the Social 

Security Act (Pub. L. 104–193) requires 

that each state receiving an AV grant 

award shall monitor, evaluate, and 

report on such programs in accordance 

with regulations. Additionally, the 

Catalog of Federal Domestic Assistance 

states that there is an application 

requirement for Grants to States for 

Access and Visitation Programs 

(93.597). The application process assists 

OCSE in complying with this 

requirement and emphasizes program 

efficiency, coordination of services, 

building support for parenting time 

services, and ensuring the safety of 

parents and children. 

Specifically, the application requires 

states to submit a detailed program plan 

indicating how they anticipate spending 

their funds within the program statue 

and regulations. The applications cover 

3 fiscal years and any changes made to 

the plan during the 3-year period will 

require a notification of change to 

OCSE. 

OCSE will review the applications to 

ensure that planned services meet the 

requirements laid out in section 

469B(e)(3) of the Social Security Act 

(Pub. L. 104–193. This review will 

include monitoring of program 

compliance and the safe delivery of 

services. In addition to monitoring, the 

report will also assist in OCSE’s ability 

to provide technical assistance to states 

that request assistance. 

The State Access and Visitation Grant 

Application is proposing changes to the 

application itself, including 

requirements for states and territories to: 

—Address disparities in access; 

—ensure the proactive identification of 

systemic barriers to AV grant services 

for people of color and other 

underserved populations; 

—describe how grant activities will 

redress such barriers; and 

—describe how outreach and 

recruitment efforts will promote 

equity in access for underserved or 

marginalized populations. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30957 

1 In this notice, ‘‘method’’ generally refers to the 

type of sterilization and ‘‘processes’’ generally 

refers to steps within that method to achieve a 

sterile device. 

The grant application also expands 

requirements for partnerships with 

domestic violence service providers to 

address the access issues experienced 

by marginalized victims of domestic 

violence. 

Respondents: Recipients of the State 

Access and Visitation Grant (54 states 

and territories). 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number of 

responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual 

burden hours 

State Access and Visitation Grant Application .................. 54 1 10 540 180 

Estimated Total Annual Burden 

Hours: 180. 

Authority: Sec. 469B(e)(3), Pub. L. 

104–193. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–10832 Filed 5–19–22; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0517] 

Medical Devices; 510(k) Sterility 

Change Master File Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA, Agency, or we) 

Center for Devices and Radiological 

Health (CDRH or Center) is announcing 

its 510(k) Sterility Change Master File 

Pilot Program (‘‘510(k) Sterility Pilot 

Program’’). The 510(k) Sterility Pilot 

Program is voluntary and intends to give 

interested companies that terminally 

sterilize single-use devices 

(‘‘sterilization providers’’) using certain 

sterilization methods a pathway to 

submit a Master File for FDA’s review. 

FDA will accept a Master File into the 

510(k) Sterility Pilot Program when it 

determines, among other things, that 

there is not a likelihood that switching 

from a fixed chamber ethylene oxide 

(EtO) sterilization method to the 

sterilization method described in the 

Master File could significantly affect the 

safety or effectiveness of a 510(k)- 

cleared device that meets the product 

definition in the Master File and that 

satisfies other conditions outlined in 

this document. If a Master File is 

accepted into the 510(k) Sterility Pilot 

Program, manufacturers of 510(k)- 

cleared devices (‘‘510(k) holders’’) may 

choose to reference the Master File in 

internal documentation in support of a 

justification for not submitting a new 

premarket notification (510(k)) under 

certain conditions as outlined in this 

document. This voluntary pilot program 

seeks to encourage industry to consider 

new, innovative ways to sterilize 

devices that reduce the potential impact 

of EtO on the environment and on 

public health, while ensuring consistent 

patient access to safe devices and 

providing a framework for future 

regulatory approaches that would help 

address potential device shortages 

related to EtO sterilization. 

DATES: FDA is seeking participation in 

the voluntary 510(k) Sterility Pilot 

Program beginning May 20, 2022. See 

the ‘‘Participation’’ section for selection 

criteria for sterilization providers to 

participate in the 510(k) Sterility Pilot 

Program and the ‘‘Procedures’’ section 

for instructions on how to submit a 

Master File for consideration for 

inclusion into the 510(k) Sterility Pilot 

Program. Up to nine eligible 

sterilization providers may be selected 

for participation in the 510(k) Sterility 

Pilot Program. 

FOR FURTHER INFORMATION CONTACT: 

Clarence W. Murray, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4536, Silver Spring 

MD 20993, 301–796–0270, 

clarence.murray@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

EtO sterilization is an important 

sterilization method that is widely used 

to keep devices safe. It is estimated that 

approximately 50 percent of all sterile 

devices in the United States are 

sterilized using EtO (Ref. 1). For many 

devices, sterilization with EtO may be 

the only method 1 currently evaluated 

that effectively sterilizes and does not 

damage the device during the 

sterilization process. However, there 

have been concerns about the effects of 

EtO exposure and environmental 

emissions. 

In 2019, FDA was made aware of 

closures of device sterilization facilities 

due to concerns about the level of EtO 

emissions (Ref. 2). The Agency closely 

monitored the situation and worked 

with device manufacturers affected by 

the closures to minimize impact to 

patients who needed device access. 

Future losses of sterilization capacity 

due to facility closure have the potential 

to result in shortages of sterile devices 

if an alternative for sterilization is not 

readily available for the devices 

sterilized at a closed facility. FDA 

continues to work with manufacturers 

on site changes, engage with 

manufacturers about potential solutions 

to shortage concerns, and collaborate 

with external stakeholders to help 

reduce barriers to the utilization of 

innovative device sterilization 

technologies. FDA has also taken several 

actions to advance device sterilization, 

including sponsoring two innovation 

challenges to identify alternatives to EtO 

sterilization methods (Ref. 3) and 

approaches to reduce EtO emissions 

(Ref. 4); convening the General Hospital 

and Personal Use Devices Panel on 

November 6 and 7, 2019 (‘‘November 

2019 Panel Meeting’’), to discuss the 

role of EtO sterilization in maintaining 

public health (84 FR 46546, September 

9, 2019; see also Ref. 5); and announcing 

an Ethylene Oxide Sterilization Master 

File Pilot Program (‘‘EtO Pilot Program’’) 

for devices subject to Premarket 

Application (‘‘PMA’’) approval (84 FR 

65162, November 26, 2019; see also Ref. 

1). 

For devices subject to 510(k) 

requirements, before most sterile 

devices are cleared for marketing, FDA 

reviews the submitted 510(k) 

information to determine, among other 

considerations, if the provided sterility 

information is adequate (e.g., in 

accordance with internationally agreed 

upon voluntary consensus standards 

that FDA recognizes). In some cases, if 

a device manufacturer changes the 

sterilization method or process for 

sterilizing the device identified in its 

original 510(k) submission, the 

manufacturer may need to submit a new 

510(k) for FDA review of these changes 

and clearance prior to marketing (Ref. 

6). However, in addition to public 


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