Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36509 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Section 503B of the FD&C act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Waiver request from electronic submission of product 

reports.

1 1 1 1 ............................. 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 214 

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

Respondents to this collection of 

information are outsourcing facilities. 

Based upon our evaluation of the 

information collection, we have 

adjusted our estimate downward by 16 

hours (from 230 to 214) annually to 

reflect more recent data. We estimate 

that each year three outsourcing 

facilities will submit a product report 

upon initial registration under section 

503B of the FD&C Act. We estimate that 

twice each year 75 outsourcing facilities 

will submit a report identifying all 

human drugs compounded in the 

facility in the previous 6 months. For 

the purposes of this estimate, each 

product’s SPL submission is considered 

a separate product response, and 

therefore each facility’s product report 

will include multiple product 

responses. We estimate that each facility 

will average 53 product responses. We 

expect each product report will consist 

of multiple product responses per 

facility and estimate that preparing and 

submitting this information 

electronically may take up to 5 minutes 

for each initial product response. 

Assuming an average of 53 product 

responses per facility, we estimate that, 

for semiannual reports, preparing and 

submitting this information 

electronically will take 1.5 minutes per 

product response. Our burden estimate 

for semiannual product report 

submissions is lower than for initial 

product reports because outsourcing 

facilities can save each product 

response once initially created and 

submitted. For subsequent reports, an 

outsourcing facility may resubmit the 

same file(s) after changing the RootID 

and version number (both SPL 

metadata), effective date (to identify the 

reporting period), and the number of 

units produced, along with other data as 

appropriate, to appropriate values for 

the reporting period. Furthermore, if a 

product was not compounded during a 

particular reporting period, no product 

response would be sent for that product 

during that reporting period. 

We expect to receive no more than 

one waiver request from the electronic 

submission process for initial product 

reports and semiannual reports, and that 

each waiver request will take 60 

minutes to prepare and submit. 

Dated: June 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13068 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–2015–N–3662] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Reagents for Detection of Specific 

Novel Influenza A Viruses 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 0910–0584. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Guidance on Reagents for Detection of 

Specific Novel Influenza A Viruses—21 

CFR Part 866 

OMB Control Number 0910–0584— 

Extension 

In accordance with section 513 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360c), FDA 

evaluated an application for an in vitro 

diagnostic device for detection of 

influenza subtype H5 (Asian lineage), 

commonly known as avian flu. FDA 

concluded that this device is properly 

classified into class II in accordance 

with section 513(a)(1)(B) of the FD&C 

Act, because it is a device for which the 

general controls by themselves are 

insufficient to provide reasonable 

assurance of the safety and effectiveness 

of the device, but there is sufficient 

information to establish special controls 

to provide such assurance. The statute 

permits FDA to establish as special 

controls many different things, 

including postmarket surveillance, 

development and dissemination of 

guidance recommendations, and ‘‘other 

appropriate actions as the Secretary [of 

HHS] deems necessary’’ (section 

513(a)(1)(B) of the FD&C Act). This 

information collection is a measure that 

FDA determined to be necessary to 

provide reasonable assurance of safety 

and effectiveness of reagents for 

detection of specific novel influenza A 

viruses. 

FDA issued an order classifying the 

H5 (Asian lineage) diagnostic device 

into class II on March 22, 2006 (71 FR 

14377), establishing the special controls 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of that device and similar future 

devices. The new classification was 

codified in 21 CFR 866.3332, a 

regulation that describes the new 


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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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