36514 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

notification; (3) consignee(s) of products 

for further manufacture; (4) additional 

product information; (5) updated 

product disposition; and (6) industry 

recall contacts. This information is 

requested by CBER through email 

notification to the submitter of the BPD 

report. This information is used by 

CBER for recall classification purposes. 

CBER estimates that 3 percent of the 

total BPD reports submitted to CBER 

would need additional information 

submitted in the addendum. CBER 

further estimates that it would take 

between 10 and 20 minutes to complete 

the addendum. For calculation 

purposes, CBER is using 15 minutes. 

Activities such as investigating, 

changing standard operating procedures 

or processes, and follow up are 

currently required under parts 211 

(approved under OMB control number 

0910–0139), 606 (approved under OMB 

control number 0910–0116), 820 

(approved under OMB control number 

0910–0073), and 1271 (approved under 

OMB control number 0910–0543) and, 

therefore, are not included in the 

burden calculation for the separate 

requirement of submitting a deviation 

report to FDA. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

600.14; Reporting of product deviations 

by licensed manufacturers ................... 3486 103 6.864 707 2 1,414 

606.171; Reporting of product deviations 

by licensed manufacturers, unlicensed 

registered blood establishments, and 

transfusion services .............................. 3486 2,008 6.883 13,821 2 27,642 

1271.350(b); HCT/P deviations ............... 3486 80 2.575 206 2 412 

Web-based Addendum ............................ 2 3486A 66 6.69 442 0.25 110.5 

Total .................................................. ........................ ........................ ........................ 15,176 ........................ 29,578.5 

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

2Three percent of the number of respondents ((2,008 + 103 + 80) × 0.03 = 66) and total annual responses to CBER ((13,821 + 707 + 206) × 

0.03 = 442). 

Our estimated burden for the 

information collection reflects an 

overall decrease of approximately 

65,014 hours and a corresponding 

decrease of 34,152 responses. We 

attribute this adjustment to a decrease in 

the number of deviation reports we 

received in FY 2021 from licensed 

manufacturers and unlicensed 

registered blood establishments under 

§ 606.171. This is likely due to our 

issuance of the revised guidance 

document entitled ‘‘Biological Product 

Deviation Reporting for Blood and 

Plasma Establishments’’ (85 FR 14682, 

March 13, 2020), which provided blood 

and plasma establishments with revised 

recommendations related to BPD 

reporting. The revised guidance 

provided a less burdensome policy for 

reporting BPDs that is consistent with 

public health and eliminated the 

reporting of post donation information 

(PDI) events as BPD reports because 

these reports were no longer unexpected 

or unforeseeable. Given the substantial 

number of PDI reports FDA has 

received, the Agency is aware that these 

events occur, and the submission of 

additional PDI reports to FDA is 

unlikely to facilitate the identification of 

manufacturing or safety issues. 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13086 Filed 6–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0721] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Accreditation of 

Third-Party Certification Bodies To 

Conduct Food Safety Audits and Issue 

Certifications 

AGENCY: Food and Drug Administration, 

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 July 18, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0750. 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. 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and Issue Certifications— 

21 CFR Part 1, Subpart M 

OMB Control Number 0910–0750— 

Extension 

This information collection helps to 

implement FDA’s Accredited ThirdParty Certification Program (also 

referred to as the third-party food 

program), established and administered 

under section 808 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 384d), and codified in 21 CFR 

part 1, subpart M (21 CFR parts 1.600 

through 1.725) of Agency regulations. 

The regulations communicate eligibility 

criteria, assessment standards, and 

establish procedures and requirements 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36515 

for participation. For more information 

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

food/importing-food-products-unitedstates/accredited-third-partycertification-program. 

Under the third-party food program, 

accreditation bodies (ABs) apply to FDA 

for recognition. Recognized ABs 

accredit third-party certification bodies 

(CBs) under the program, except in 

limited circumstances. The accredited 

CBs conduct food safety audits and 

issue food or facility certifications to 

eligible foreign entities. FDA uses 

certifications issued by accredited thirdparty auditors/CBs in deciding whether 

to admit certain imported food (both 

food for human and other animals) into 

the United States. Under the third-party 

program, FDA may grant recognition of 

an AB for up to 5 years from the date 

of recognition. Current third-party 

program AB participants are recognized 

for the duration from 2018 to 2023 and 

will need to submit renewal of 

recognition applications to continue 

their participation. 

There are approximately 200,000 

foreign food (both food for human and 

other animals) exporters who offer their 

food products for import into the United 

States. These foreign food exporters 

include approximately 130,000 food 

production facilities and approximately 

71,000 farms. A proportion of these 

foreign food exporters may offer food 

subject to mandatory certification 

requirements under section 801(q)(3) of 

the FD&C Act (21 U.S.C. 381(q)(3)). In 

that case, to continue exporting food 

products into the United States, eligible 

entities must either obtain certification 

from a CB accredited under the thirdparty program, or obtain certification 

from a foreign government designated 

by FDA. We assume in any given year, 

75 foreign food exporters will be subject 

to requirements in section 801(q) of the 

FD&C Act. 

Participating in the third-party 

accreditation program helps reduce the 

number of redundant audits necessary 

to assess compliance with food safety 

requirements of the FD&C Act and 

applicable regulations. Required data 

elements are submitted using FDA’s 

Unified Registration Listing System 

(FURLS), an electronic portal (Forms 

FDA 3997 for ABs and 3997a for CBs) 

that enables respondents to complete 

data fields and provide information to 

FDA electronically. The AB and CB 

portals provide a standardized format 

for entering information, prompting 

respondents for input and facilitating 

FDA’s review of the submittal. 

Instructions may be accessed at https:// 

www.fda.gov/food/importing-foodproducts-united-states/accredited-thirdparty-certification-program. 

Respondents to the collection of 

information are eligible entities seeking 

audits, certification, and/or 

recertification by accredited CBs 

participating in the third-party program, 

and ABs and CBs seeking to comply 

with the recognition requirements. An 

eligible entity is a foreign entity in the 

import supply chain of food for 

consumption in the United States that 

chooses to be subject to a food safety 

audit conducted by an accredited thirdparty CB. 

In the Federal Register of February 

16, 2022, (87 FR 8846), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part 1, subpart M Number of 

respondents 

Number of 

responses per 

respondent 2

Total annual 

responses 

Average burden per 

response 2 Total hours 

AB applications, renewals, notifications, revocations 25 11.36 284 3.18 .......................... 903 

CB certifications, regulatory audits and assessments, notifications.208 147.29 30,638 0.25 (15 minutes) .... 7,661 

CB applications for direct accreditation & renewal ... 1 1 1 90 ............................. 90 

Total .................................................................... ........................ ........................ 30,923 .................................. 8,654 

1 We estimate no capital costs or operating and maintenance costs for the information collection. 2 Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part 1, subpart M Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

Total annual 

records 

Average burden per 

recordkeeping 2 Total hours 

AB documenting certification procedures; maintaining applicable records.25 426.56 10,664 0.25 (∼15 minutes) .. 2,677 

AB establishing and updating public list of CBs ....... 25 1 25 52.8 .......................... 1,320 

CB documenting procedures for accreditation; maintaining applicable records (audits, certifications, 

serious risks).

208 112.72 23,446 0.35 (∼20 minutes) .. 8,228 

CB establishing & updating public list of eligible entities.208 1.31 273 44.19 ........................ 12,064 

Contract modification 2 ............................................... 7 9 63 2 ............................... 126 

Total .................................................................... ........................ ........................ 34,471 .................................. 24,415 

1 We estimate no capital costs, or operating and maintenance costs for the information collection. 2 Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours. 

We include in our estimate reporting 

burden attributable to required 

submissions, including notifications, to 

FDA; and recordkeeping burden 

attributable to the time we assume 

necessary for searching data sources, 

and preparing and maintaining records 

described in the applicable regulations. 

We estimate that 25 ABs will accredit 


lotter on DSK11XQN23PROD with NOTICES1
36516 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

1For the purpose of this request for information, 

the term ‘‘jurisdiction’’ includes the District of 

Columbia, the Republic of the Marshall Islands, the 

Federated States of Micronesia, the Republic of 

Palau, the Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, American Samoa, and the 

Commonwealth of the Northern Mariana Islands. 

2For the purpose of this request for information, 

the EHDI system is defined as ‘‘families, consumers, 

providers, services, and programs that work 

towards developing coordinated and 

comprehensive state and territory systems so that 

families with newborns, infants, and young 

children who are deaf or hard of hearing receive 

appropriate and timely services that include 

hearing screening, diagnosis, and intervention.’’ 

Early Hearing Detection and Intervention Program 

Notice of Funding Opportunity HRSA–20–047’’? 

CBs who conduct food safety audits of 

foreign eligible entities that offer food 

for import to the United States. We also 

estimate the 208 accredited CBs will 

participate in the third-party program. 

In addition, we expect that one CB will 

apply and participate in the third-party 

program via direct accreditation by 

FDA. Finally, we attribute nominal 

burden to recordkeeping attendant to 

contractual modifications that may be 

part of accreditation. 

Based on a review of the information 

collection since last OMB approval, we 

have made only nominal adjustments to 

our burden estimate. 

Dated: June 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13071 Filed 6–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Request for Information: Early Hearing 

Detection and Intervention Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of request for public 

comment. 

SUMMARY: HRSA’s Early Hearing 

Detection and Intervention (EHDI) 

Program is requesting input from the 

public to inform future EHDI program 

development. 

DATES: Submit comments no later than 

July 18, 2022. 

ADDRESSES: Submit electronic 

comments to ehdi@hrsa.gov. Please 

submit your response only one time by 

July 18, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Battiste, MPH at ehdi@hrsa.gov 

or (301) 443–0223. 

SUPPLEMENTARY INFORMATION: HRSA’s 

EHDI Program, authorized under 42 

U.S.C. of the Public Health Service Act, 

seeks to enable states, jurisdictions, 

families, and clinical, educational, and 

social service providers to develop 

coordinated systems of care so that 

newborns, infants, and young children 

who are deaf or hard of hearing are 

identified as early as possible and 

receive the services they need. Early 

involvement can help these children 

meet age-appropriate language, literacy, 

social-emotional, and other 

developmental milestones. HRSA 

currently funds 59 states and 

jurisdictions 1 through the EHDI grants 

program in order to (1) increase health 

professionals’ engagement with and 

knowledge of the EHDI system,2 (2) 

improve access to early intervention 

services and language acquisition, and 

(3) improve family engagement, 

partnership, and leadership in EHDI 

systems. The HRSA-funded National 

Technical Resource Center supports 

states and territories by providing 

technical assistance and resources in 

order to meet EHDI program goals and 

objectives. 

HRSA investments also support 

family engagement and workforce 

development related to EHDI. For 

example, the Family Leadership in 

Language and Learning program aims to 

strengthen family leadership and 

inclusion of families, parents and 

caregivers of children who are deaf or 

hard of hearing within the EHDI system. 

In addition, HRSA funds the Leadership 

Education in Neurodevelopmental and 

Related Disabilities program, authorized 

under the Public Health Service Act, to 

support workforce development through 

audiology training grants. More 

information about the HRSA EHDI 

program is available online at: https://

mchb.hrsa.gov/maternal-child-healthinitiatives/early-hearing-detection-andintervention.html. 

Responses 

HRSA is seeking responses that 

address the following questions. A 

response to each question is not 

required. 

1. What strategies or programs are 

needed to support EHDI programs to 

ensure that all newborns are screened 

by 1 month of age, a diagnosis is made 

by 3 months of age, and children who 

are deaf or hard of hearing are enrolled 

in and start to receive intervention 

services by 6 months of age? 

2. What strategies should be 

considered to support the timely 

identification and receipt of services for 

young children up to age 3? 

3. What strategies should be 

considered to ensure that infants and 

young children receive screening and 

diagnosis services that are high quality 

and evidence-based? 

4. What strategies should be 

considered to ensure that providers 

collect and report high quality data on 

hearing screening, diagnosis, and 

follow-up to EHDI programs for public 

health surveillance? 

5. What strategies or programs would 

ensure that families of children who are 

deaf or hard of hearing receive 

information that is accurate, 

comprehensive, up-to-date, and 

evidence-based, as appropriate, to allow 

families to make important decisions for 

their children in a timely manner, 

including decisions with respect to the 

full range of assistive hearing 

technologies and communications 

modalities, as appropriate? 

6. What strategies would help ensure 

families, parents, and caregivers are 

continuously engaged as active partners 

in the EHDI system? 

7. What approaches that foster familyto-family and deaf and hard of hearing 

consumer-to-family supports by families 

and adults who are deaf or hard of 

hearing should be considered? 

8. What new evidence-based or 

promising approaches that help deaf or 

hard of hearing children meet language, 

literacy, social, emotional, and other 

developmental milestones should be 

considered within EHDI Programs/the 

EHDI system? 

9. How has COVID–19 impacted the 

EHDI system of care, including the 

ability of EHDI programs to share or 

report information in a timely manner? 

Are there any notable promising 

practices or approaches used in 

response that should be further 

explored? 

10. What ongoing and emerging gaps 

in access to services are present within 

the EHDI system? Are there populations 

that are experiencing inequities in 

access to timely identification and 

receipt of services? What approaches 

should be used to address these gaps? 

Respondents can also provide 

additional comments or 

recommendations that are not 

specifically linked to the questions 

above. All responses may but are not 

required to identify the individual’s 

name, address, email, telephone 

number, professional or organizational 

affiliation, background or area of 

expertise (e.g., program participant, 

family member, clinician, public health 

worker, researcher, EHDI Coordinator, 

etc.), and topic/subject matter. 

Information obtained as a result of this 

request for information (RFI) may be 


lotter on DSK11XQN23PROD with NOTICES1