36510 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

classification for reagents for detection 

of specific novel influenza A viruses 

and sets forth the special controls that 

help to provide a reasonable assurance 

of the safety and effectiveness of devices 

classified under that regulation. The 

regulation refers to the document 

entitled ‘‘Class II Special Controls 

Guidance Document: Reagents for 

Detection of Specific Novel Influenza A 

Viruses,’’ which provides 

recommendations for measures to help 

provide a reasonable assurance of safety 

and effectiveness for these reagents. The 

guidance recommends that sponsors 

obtain and analyze postmarket data to 

ensure the continued reliability of their 

device in detecting the specific novel 

influenza A virus that it is intended to 

detect, particularly given the propensity 

for influenza viruses to mutate and the 

potential for changes in disease 

prevalence over time. The guidance 

document is available on our website at: 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm078583.htm. 

As updated sequences for novel 

influenza A viruses become available 

from the World Health Organization, 

National Institutes of Health, and other 

public health entities, sponsors of 

reagents for detection of specific novel 

influenza A viruses will collect this 

information, compare them with the 

primer/probe sequences in their 

devices, and incorporate the result of 

these analyses into their quality 

management system, as required by 21 

CFR 820.100(a)(1). These analyses will 

be evaluated against the device design 

validation and risk analysis required by 

21 CFR 820.30(g) to determine if any 

design changes may be necessary. 

In the Federal Register of January 25, 

2022 (87 FR 3812), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping regarding reagents for detection of specific 

novel influenza A viruses ................................................. 12 2 24 15 360 

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

Our estimated burden for the 

information collection reflects an 

overall increase of 330 hours and a 

corresponding increase of 22 records. 

We attribute this adjustment to an 

increase in the number of devices of this 

type being manufactured over the last 

few years. 

Dated: June 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13069 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–2018–N–4042] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishing and 

Maintaining Lists of U.S. 

Establishments With Interest in 

Exporting Center for Food Safety and 

Applied Nutrition-Regulated Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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: Submit written comments 

(including recommendations) 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 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. The OMB 

control number for this information 

collection is 0910–0509. 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–12M, 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. 

Establishing and Maintaining Lists of 

U.S. Establishments With Interest in 

Exporting CFSAN-Regulated Products 

OMB Control Number 0910–0509— 

Extension 

The United States exports a large 

volume and variety of foods in 

international trade. Foreign 

governments often require official 

certification from the responsible 

authority of the country of origin about 

imported foods and establishments 

involved in their production, storage, or 

distribution. Some foreign governments 

establish additional requirements with 

which exporters are required to comply 

and ask for additional assurances from 

the responsible authority. Importing 

countries may require, and FDA may 

provide, official certification or 

assurances for food products in different 

forms, including certificates that 

accompany specific products or lists of 

establishments and products that 

comply with certain requirements. 

To facilitate exports of food subject to 

importing country listing requirements, 

FDA has historically provided official 

certification in the form of country- and 

product-specific export lists that 

include establishments and their 

products when: (1) the establishment 

has expressed interest in exporting their 

products to these countries; (2) the 

establishment and the products are 

subject to FDA’s jurisdiction; and (3) the 

establishment can demonstrate that it is 

in good regulatory standing for the 


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Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36511 

products it intends to export and the 

products are expected to comply with 

applicable FDA requirements. As we 

advise in the guidance document 

‘‘Establishing and Maintaining a List of 

U.S. Milk and Milk Product, Seafood, 

Infant Formula, and Formula for Young 

Children Manufacturers/Processors with 

Interest in Exporting to China,’’ 

(November 2018), available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

guidance-industry-establishing-andmaintaining-list-us-milk-and-milkproduct-seafood-infant-formula, FDA 

considers ‘‘good regulatory standing’’ as 

meaning that an establishment is in 

substantial compliance with applicable 

FDA requirements and is not the subject 

of a pending enforcement action (e.g., an 

injunction or seizure) or pending 

administrative action (e.g., a warning 

letter). 

FDA has generally published 

guidance documents for these countryand product-specific lists under the 

authority of section 701(h) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 371(h)), which 

authorizes the Secretary of Health and 

Human Services (the Secretary) to 

develop guidance documents with 

public participation presenting the 

views of the Secretary on matters under 

the jurisdiction of FDA. The guidance 

documents generally explain what 

information establishments should 

submit to FDA to be considered for 

inclusion on the lists and what criteria 

FDA intends to use to determine 

eligibility for placement on the lists. 

The guidance documents also explain 

how FDA intends to update the lists and 

communicate any new information to 

the governments that requested the lists. 

Finally, the guidance documents note 

that the information is provided 

voluntarily by establishments with the 

understanding that it may be posted on 

FDA’s external website and that it will 

be communicated to, and possibly 

further disseminated by, the government 

that requested the list; thus, FDA 

considers the information on the lists to 

be information that is not protected 

from disclosure under 5 U.S.C. 

552(b)(4). The guidance documents 

include ‘‘Establishing and Maintaining a 

List of U.S. Dairy Product 

Manufacturers/Processors with Interest 

in Exporting to Chile’’ and ‘‘Establishing 

and Maintaining a List of U.S. Milk and 

Milk Product, Seafood, Infant Formula, 

and Formula for Young Children 

Manufacturers/Processors with Interest 

in Exporting to China.’’ Additional 

information about FDA’s Food Export 

Lists program is available at https://

www.fda.gov/food/exporting-foodproducts-united-states/food-export-lists. 

FDA has also published a guidance 

document on export certification that 

contains useful information that applies 

to export lists entitled, ‘‘FDA Export 

Certification,’’ (August 2021) available 

at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/fda-export-certification. 

Foreign governments are increasingly 

relying on certification as a strategy for 

ensuring the safety of imported food 

products, and many countries have 

announced new requirements for lists of 

establishments and products certified to 

comply with certain food safety 

requirements. FDA is committed to 

facilitating compliance with new listing 

requirements for U.S. establishments 

that export FDA-regulated food 

products. We also understand that 

complying with multiple country- and 

product-specific listing requirements 

can be burdensome to U.S. 

establishments. For this reason, we plan 

to create a new list of establishments 

and products certified for export that 

would be offered to importing countries 

in lieu of country-specific lists. 

Application for inclusion on all 

export lists will continue to be 

voluntary. However, some foreign 

governments may require inclusion on 

export lists as a precondition for market 

access or to satisfy other importing 

country registration or approval 

requirements. FDA uses the Export 

Listing Module (ELM), an electronic 

system (Form FDA 3972), to receive and 

process applications for inclusion on 

export lists for Center for Food Safety 

and Applied Nutrition (CFSAN)- 

regulated products. The ELM allows 

applicants to provide information about 

the products intended for export, the 

establishment that produces those 

products, evidence of the 

establishment’s compliance with 

applicable requirements for the 

products intended for export, and any 

additional data or information (such as 

third-party certifications) that foreign 

governments may require. We request 

that this information be updated every 

2 years. Additional information and 

screenshots of the ELM are available at 

https://www.fda.gov/food/exportingfood-products-united-states/foodexport-lists. If an establishment is 

unable to apply via the ELM, it may 

contact CFSAN and request assistance. 

We use the information submitted by 

establishments to determine eligibility 

for certification and inclusion on the 

export lists, which may be published on 

our website or the websites of foreign 

governments. The purpose of the lists is 

to help CFSAN-regulated industries 

meet the import requirements of foreign 

governments. This collection of 

information is intended to cover all of 

CFSAN’s existing export lists, as well as 

any additional export lists established 

by the center. 

FDA notes that section 801 of the 

FD&C Act (21 U.S.C. 381) also provides 

that FDA may charge a fee of up to $175 

if the Agency issues an export 

certification within 20 days of receipt of 

a complete request for such 

certification. 

Description of Respondents: 

Respondents to this collection of 

information include U.S. establishments 

subject to FDA/CFSAN jurisdiction that 

wish to be included on export lists. 

In the Federal Register of January 25, 

2022 (87 FR 3814), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. One comment was received 

offering general support for the 

information collection and offered 

points FDA might consider as it 

develops and maintains such lists. FDA 

appreciates this comment and 

continuously works to provide 

interested persons with useful 

information as its limited resources 

permit. The comment did not suggest 

alternative estimates. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

New request ............................................................... 167 5 835 1 ............................... 835 

New request + third-party certification ...................... 85 2 170 22 ............................. 3,740 

Biennial update .......................................................... 132 4 528 0.5 (30 minutes) ...... 264 

Biennial update + third-party certification .................. 58 2 116 22 ............................. 2,552 


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36512 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Occasional updates ................................................... 60 2 120 0.5 (30 minutes) ...... 60 

Total .................................................................... ........................ ........................ 1,769 .................................. 7,451 

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

Based on a review of the information 

collection since our last request for 

OMB approval, the estimated burden for 

this information collection has 

decreased. The number of respondents 

has declined dramatically since we 

transitioned to using the ELM, which 

also allows us to collect more precise 

data. These changes resulted in overall 

decreases of 3,421 responses and 14,837 

burden hours. 

Dated: June 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13074 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–2009–N–0545] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biological 

Products: Reporting of Biological 

Product Deviations and Human Cells, 

Tissues, and Cellular and TissueBased Product Deviations in 

Manufacturing 

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 requirements relating to the 

reporting of biological product 

deviations and human cells, tissues, and 

cellular and tissue-based product (HCT/ 

P) deviations in manufacturing, and 

Forms FDA 3486 and 3486A. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 16, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 16, 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– 

2009–N–0545 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Biological Products: Reporting of 

Biological Product Deviations and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Deviations in 

Manufacturing; Forms FDA 3486 and 

3486A.’’ 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 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 


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