3812 Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Exports Notification and 

Recordkeeping Requirements—21 CFR 

1.101 

OMB Control Number 0910–0482— 

Extension 

Sections 801 and 802 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 381 and 21 U.S.C. 382) 

charge the Secretary of Health and 

Human Services, through FDA, with the 

responsibility of helping to ensure that 

exports of unapproved new drugs, 

biologics, devices, animal drugs, food, 

cosmetics, and tobacco products that are 

not to be sold in the United States meet 

the requirements of the country to 

which the product is to be exported. 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or offered for sale in domestic 

commerce in the United States as 

allowed under section 801(e) of the 

FD&C Act. In general, the notification 

identifies the product being exported 

(e.g., name, description, and in some 

cases, country of destination) and 

specifies where the notifications were 

sent. These notifications are sent only 

for an initial export. Subsequent exports 

of the same product to the same 

destination or to certain countries 

identified in section 802(b) of the FD&C 

Act would not result in a notification to 

FDA. 

Respondents to the information 

collection are exporters of products that 

may not be sold in the United States and 

are regulated by FDA’s Center for Drug 

Evaluation and Research (CDER); Center 

for Biologics Evaluation and Research 

(CBER); Center for Devices and 

Radiological Health (CDRH); Center for 

Veterinary Medicine (CVM); Center for 

Food Safety and Applied Nutrition 

(CFSAN); and Center for Tobacco 

Products. Respondents to this collection 

of information maintain records 

demonstrating their compliance with 

the requirements in 21 CFR 1.101. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 

section 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

1.101(d) (CBER) .................................................................. 5 92 460 15 6,900 

1.101(d) (CDER) .................................................................. 5 180 900 15 13,500 

1.101(d) (CDRH) .................................................................. 160 1 160 15 2,400 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,800 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR 

section 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1.101(b), (c), and (e) (CBER, CDER, CDRH, CFSAN, and 

CVM) ................................................................................ 320 3 960 22 21,120 

1.101(b) Office of International Programs only ................... 1 189 189 22 4,158 

1.101(b) (currently regulated Tobacco Products) ................ 322 3 966 22 21,252 

Total .............................................................................. ........................ ........................ ........................ ........................ 46,530 

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

Based on a review of Agency data, we 

are retaining the currently approved 

burden estimates associated with the 

individual reporting and recordkeeping 

elements. 

Dated: January 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01372 Filed 1–24–22; 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; Proposed Collection; 

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, 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 associated with the guidance 

on reagents for detection of specific 

novel influenza A viruses. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 28, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices 3813 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 28, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 28, 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– 

2015–N–3662 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

on Reagents for Detection of Specific 

Novel Influenza A Virus.’’ 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 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: 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, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
3814 Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices 

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 

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. 

FDA estimates that 12 respondents 

will be affected annually. The 

respondent will collect this information 

twice per year; each response is 

estimated to take 15 hours. This results 

in a total data collection burden of 360 

hours. 

The guidance also refers to previously 

approved information collections found 

in FDA regulations. The collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485; the collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; and the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073. 

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: January 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01369 Filed 1–24–22; 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; Proposed Collection; 

Comment Request; Establishing and 

Maintaining Lists of United States 

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 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 the information 

collection associated with export lists 

for products regulated by the Center for 

Food Safety and Applied Nutrition 

(CFSAN). 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 28, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 28, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 28, 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: 


khammond on DSKJM1Z7X2PROD with NOTICES