Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Notices 29749 

fit testing methods), processes, 

techniques, tools, and materials that 

support the development and use of PPE 

worn by individuals. 

In 2006, the NIOSH Personal 

Protective Technology Laboratory 

(NPPTL) began an initiative to develop 

and execute a comprehensive strategic 

approach to HCP protection. The 

resulting NIOSH Healthcare PPT Action 

Plan focused resources on and raised 

awareness about the PPT needs of HCP 

during a potential influenza pandemic. 

NIOSH undertook a research agenda to 

advance clinical practices, drive 

performance standards development, 

and inform regulation. In addition, 

NIOSH carried out an information 

dissemination program to apprise 

healthcare organizations and HCP about 

the roles and importance of PPE in 

protecting themselves. The Action Plan 

has been updated several times since its 

inception. The most recent plan (2013– 

18) focused on PPE used to reduce 

exposures to viral respiratory pathogens, 

including the influenza virus. 

Reflecting on the nation’s past decade 

of experiences with infectious diseases 

(e.g., influenza, Ebola, and coronavirus) 

and non-infectious hazards (e.g., 

antineoplastic and other hazardous 

drugs), NIOSH recognizes a growing 

need for its unique capabilities related 

to PPT research, development, 

performance standards and test 

methods, and conformity assessment. 

To respond to this growing need, 

NIOSH developed DRAFT NIOSH 

Healthcare PPT Targets for 2020 to 2030 

(Draft PPT Targets), which have 

informed NIOSH’s PPT efforts since 

2020. The public health response to the 

COVID–19 pandemic has delayed 

NIOSH’s efforts to obtain public input 

on the PPT Targets; NIOSH will finalize 

the PPT Targets after receipt of the 

requested public input. To view the 

Draft PPT Targets, please visit https://

www.cdc.gov/niosh/npptl/ 

hospresptoolkit/ 

DraftHealthcarePPT.html. 

Information Needs: Additional data 

and information are needed to assist 

with finalizing the Draft PPT Targets. 

Interested persons or organizations are 

invited to submit applicable materials, 

including published and unpublished 

reports and research findings, that 

NIOSH may consider to: 

• Align its activities with other 

national efforts related to PPT; 

• Coordinate and prioritize NIOSH 

targets with complementary efforts by 

other entities; 

• Explore opportunities to collaborate 

with other entities; 

• Determine the level of effort needed 

to address specific targets; 

• Explore additional or alternative 

technical approaches; and 

• Explore additional knowledge gaps 

requiring support until 2030. 

Disclaimer: This notice is intended for 

planning purposes; it does not 

constitute a formal announcement for 

comprehensive applications. In 

accordance with Federal Acquisition 

Regulation 48 CFR 15.201(e), responses 

to this notice are not offers and cannot 

be accepted by the Government to form 

a binding award. NIOSH will not 

provide reimbursement for costs 

incurred in commenting on this notice. 

NIOSH will not respond to individual 

public comments or publish publicly a 

compendium of responses. An 

informational submission in response to 

this notice does not create any 

commitment by or on behalf of CDC or 

HHS to develop or pursue any program 

or ideas discussed. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2022–10413 Filed 5–13–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–2854] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Premarket 

Tobacco Product Applications and 

Recordkeeping Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 ‘‘Premarket 

Tobacco Product Applications and 

Recordkeeping Requirements.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 15, 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 July 15, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 15, 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– 

2019–N–2854 for ‘‘Premarket Tobacco 

Product Applications and 

Recordkeeping Requirements.’’ 

Received comments, those filed in a 


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29750 Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Notices 

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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Premarket Tobacco Product 

Applications and Recordkeeping 

Requirements—21 CFR 1114 

OMB Control Number 0910–0879— 

Extension 

This information collection supports 

the requirements for the content, format, 

submission recordkeeping, and 

postmarket reporting requirements of a 

premarket tobacco product application 

(PMTA). Section 910(a) (21 U.S.C. 

387j(a)) of the Federal Food, Drug, and 

Cosmetic Act (FD&C) established 

requirements for premarket review of 

new tobacco products and the 

implementing regulations are found in 

21 CFR subchapter K, part 1114 (part 

1114). 

An applicant may submit a PMTA to 

demonstrate that a new tobacco product 

meets the requirements to receive a 

marketing granted order. A new tobacco 

product may not be introduced or 

delivered for introduction into interstate 

commerce under this part until FDA has 

issued a marketing granted order for the 

product (§ 1114.5). Further, § 1114.7 

describes the required content and 

format of the PMTA. The PMTA must 

contain sufficient information for FDA 

to determine whether any of the 

grounds for denial specified in section 

910(c)(2) of the FD&C Act apply. The 

application must contain the following 

sections: General information, 

descriptive information, product 

samples, labeling, a statement of 

compliance with 21 CFR part 25, a 

summary, product formulation, 

manufacturing, health risk 

investigations, effect on the population 

as a whole, and a certification 

statement. 

Submitters can visit the following 

web page which describes the process 

for submitting a PMTA (https://

www.fda.gov/tobacco-products/marketand-distribute-tobacco-product/ 

premarket-tobacco-productapplications). 

After submission of a PMTA FDA may 

request, and an applicant may submit, 

an amendment to a pending PMTA. 

FDA generally expects that when an 

applicant submits a PMTA, the 

submission will include all information 

required by section 910(b)(1) of the 

FD&C Act and part 1114 to enable FDA 

to determine whether it should 

authorize the marketing of a new 

tobacco product. However, FDA 

recognizes that additional information 

may be needed to complete the review 

of a PMTA and, therefore FDA allows 

the submission of amendments to a 

pending application. 

An applicant may transfer ownership 

of its PMTA at any time, including 

when FDA has yet to act on it. Section 

1114.13 describes the steps that an 

applicant would be required to take 

when it changes ownership of a PMTA. 

This section is intended to facilitate 

transfers of ownership and help ensure 

that FDA has current information 

regarding the ownership of a PMTA. 

A supplemental PMTA are an 

alternative format of submitting a PMTA 

(§ 1114.15). Applicants that have 

received a marketing granted order 

would be able to submit a supplemental 

PMTA to seek marketing authorization 

for a new tobacco product that results 

from a modification or modifications to 

the original tobacco product that 

received the marketing granted order. 

FDA restricts the use of supplemental 

PMTAs to only changes that require the 

submission of limited information or 

revisions to ensure that FDA can 

efficiently review the application. 

If an applicant receives a no 

marketing granted order, they may 

submit a resubmission to respond to the 

deficiencies outlined (§ 1114.17). A 

resubmission may be submitted for the 

same tobacco product that received a 

marketing denial order or for a different 


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Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Notices 29751 

new tobacco product that results from 

changes necessary to address the 

deficiencies outlined in a marketing 

denial order. This application format 

allows an applicant to address the 

deficiencies described in a marketing 

denial order without having to 

undertake the effort of submitting a 

standard PMTA. The resubmission 

format is not available for PMTAs that 

FDA refused to accept, refused to file, 

cancelled, or administratively closed, or 

that the applicant withdrew because 

FDA has not previously completed 

reviews of such applications upon 

which it can rely, and such applications 

may need significant changes to be 

successfully resubmitted. 

FDA requires applicants that receive a 

marketing granted order to submit 

postmarket reports. Postmarket reports 

determine or facilitate a determination 

of whether there may be grounds to 

withdraw or temporarily suspend a 

marketing granted order. Applicants are 

required to submit two types of 

postmarket reports after receiving a 

marketing granted order: Periodic 

reports and adverse experience reports. 

Periodic reports are required to be 

submitted within 60 calendar days of 

the reporting date specified in the 

marketing granted order. Applicants 

would also be required to report all 

serious and unexpected adverse 

experiences associated with the tobacco 

product that have been reported to the 

applicant or of which the applicant is 

aware. The serious and unexpected 

adverse experience reports must be 

submitted to the Center for Tobacco 

Products’ Office of Science through the 

HHS Safety Reporting Portal (https://

www.safetyreporting.hhs.gov/) within 

15 calendar days after receiving or 

becoming aware of a serious or 

unexpected adverse experience. FDA’s 

Safety Reporting Portal is approved 

under OMB control number 0910–0645. 

Applicants receiving a marketing 

granted order are required to maintain 

all records necessary to facilitate a 

determination of whether there are or 

may be grounds to withdraw or 

temporarily suspend the marketing 

granted order, including records related 

to both the application and postmarket 

reports, and ensure that such records 

remain readily available to the Agency 

upon request (§ 1114.45). 

The Consolidated Appropriations Act 

of 2022 (the Appropriations Act), 

enacted on March 15, 2022, amended 

the definition of the term ‘‘tobacco 

product’’ in section 201(rr) (U.S.C. 

321(rr)) of the FD&C Act to include 

products that contain nicotine from any 

source. As a result, non-tobacco nicotine 

(NTN) products that were not 

previously subject to the FD&C Act (e.g., 

products containing synthetic nicotine) 

are now subject to all of the tobacco 

product provisions in the FD&C Act 

beginning on April 14, 2022, including 

the requirement of premarket review for 

new tobacco products. The 

Appropriations Act also makes all rules 

and guidances applicable to tobacco 

products apply to NTN products on that 

same effective date, which includes the 

Premarket Tobacco Product Application 

and Recordkeeping Requirements final 

rule. Additionally, the Appropriations 

Act includes a transition period for 

premarket review requirements, 

directing companies to submit PMTAs 

for NTN products by May 14, 2022, to 

receive an additional 60-day period of 

marketing without being considered in 

violation of premarket review 

requirements. On April 14, 2022, OMB 

granted an emergency clearance under 

this collection to include NTN products 

and its associated burden. OMB granted 

a 6-month approval, and as such per the 

requirements of the PRA, the Agency is 

seeking comment on these new 

estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part; activity; form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

1114.5; Submission of Standard Bundled 

PMTAs 2.

1 1 1 1,713 ............................. 1,713 

PMTA Submission; Form FDA 4057 .................... 39 1 39 .75 (45 minutes) ........... 29 

PMTA Amendment and General Correspondence 

Submission; Form FDA 4057a.

39 14 546 .16 (10 minutes) ........... 87 

PMTA Grouping Submission; Form FDA 4057b .. 39 1 39 .75 (45 minutes) ........... 29 

1114.41; Reporting Requirements (periodic reports).4 1 4 50 .................................. 200 

1114.9; Amendments ............................................ 24 2 48 188 ................................ 9,024 

1114.13; Change in Ownership ............................ 1 1 1 1 .................................... 1 

1114.15; Supplemental applications ..................... 2 1 2 428 ................................ 856 

1114.17; Resubmissions ...................................... 3 1 3 565 ................................ 1,695 

1114.41(a)(2); Adverse Experience Reports ........ 4 6 24 1 .................................... 24 

1114.49(b) and (c); Waiver from Electronic Submission.1 1 1 .25 (15 minutes) ........... .25 

Total ............................................................... ........................ ........................ ........................ ....................................... 13,658 

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

2FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for a number of similar or related products. We estimate that a bundle will contain on average between 6 and 11 distinct products. 

Table 1 describes the estimated 

annual reporting burden. FDA has based 

these estimates on the full analysis of 

economic impacts and experience with 

current PMTA submissions received 

under OMB control number 0910–0768 

(which covers the burden for electronic 

nicotine delivery system (ENDS) 

products PMTA submissions). This 

average represents a wide range of hours 

that will be required for these 

applications under different 

circumstances, with some requiring 

more hours (e.g., as many as 5,000 hours 

for early applications that involve 

complex products and for which the 

company has no experience conducting 

studies or preparing analysis of public 

health impacts, or for which reliance on 

master files is not possible) as well as 

many requiring fewer hours (e.g., as few 

as 50 hours for applications for products 

that are very similar to other new 

products). FDA estimates that it will 


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take each respondent approximately 

1,500 hours to prepare a PMTA seeking 

an order from FDA allowing the 

marketing of a new tobacco product. 

FDA also estimates that it would on 

average take an additional 213 hours to 

prepare an environmental assessment 

(EA) in accordance with the 

requirements of 21 CFR 25.40, for a total 

of 1,713 hours per PMTA application. 

FDA assumes that firms will submit 

all applications as PMTA bundles. We 

also considered updated data on market 

consolidation that has occurred since 

the Deeming Rule published for 

originally regulated products that would 

receive marketing granted orders 

through the PMTA pathway. For 

originally regulated products we expect 

to receive one full PMTA submission for 

a total of 1,713 hours. We believe that 

bundling PMTAs results in efficiencies 

for applicants when compared to 

submitting standalone, full-text 

submissions for each product. We 

expect to receive bundled PMTAs where 

applicants can use the same evidence to 

support PMTAs for similar or related 

products. Bundling PMTAs into a single 

submission would eliminate the 

administrative burden of having to 

reproduce the same evidence in a 

standalone PMTA for each product. 

FDA has three forms for use when 

submitting PMTA information to the 

Agency. Form FDA 4057 for use when 

submitting PMTA single and bundled 

submissions. FDA estimates that 39 

respondents will submit PMTA bundles 

using this form at 0.75 (45 minutes) per 

response. Included in this estimate are 

the 15 new expected bundles submitted 

for NTN products. The number 39 is 

accounting for the bundles of ENDS 

products and the 1 bundle we expect to 

receive yearly for originally regulated 

products for a total of 29 hours. 

Form FDA 4057a for use when firms 

are submitting amendments and other 

general correspondence. Our estimate is 

0.16 (10 minutes) per response to fill out 

this form. Included in this estimate are 

the 15 new expected submissions 

submitted from NTN products. We 

estimate there will be at least 14 

amendments per application for a total 

of 87 hours. With most applications 

being submitted toward the end of our 

3-year range, we expect fewer 

amendments during this period. 

However, FDA expects correspondence 

from earlier applications to be 

submitted during this period. 

Form FDA 4057b assists industry and 

FDA in identifying the products that are 

the subject of a submission where an 

applicant groups multiple PMTAs into a 

single submission (referred to as a 

bundled submission or a grouped 

submission). FDA has previously stated 

that one approach to submitting PMTAs 

could be to group applications for 

products that are both from the same 

manufacturer or domestic importer and 

in the same product category and 

subcategory into a single submission. 

The form assists applicants in providing 

the unique identifying information for 

each product in a grouped submission 

of PMTAs. A respondent would utilize 

Form FDA 4057b once for each 

submission containing more than one 

PMTA. We assume the submitter could 

include from 2 to 2,000 products in each 

Form FDA 4057b. Entering data for up 

to 2,000 rows can take approximately 4 

hours on average per Form FDA 4057b 

for manual data entry. We reflect the 

average time of 45 minutes per response 

based on the assumption that we expect 

to receive an average of nine bundled 

products per submission. Included in 

this estimate are the 15 new expected 

submissions submitted from NTN 

products. Assuming 45 minutes per 

Form FDA 4057b for 39 applications, we 

estimate a total burden of 29 hours for 

this activity. 

FDA estimates under § 1114.41 that 

four respondents will submit a periodic 

report. This number is based on the 

average number of periodic report 

submissions expected between 2020– 

2022 and the addition of NTN products. 

The Agency estimates that periodic 

reports will take on average of 50 hours 

per response for a total of 200 hours. 

Firms must also submit adverse 

experience reports for tobacco products 

with marketing orders. We assume the 

same number of firms submitting 

periodic reports will submit adverse 

experience reports. Currently, firms may 

voluntarily submit adverse experience 

reports using Form FDA 3800 under 

OMB control number 0910–0645. We 

have based our estimates on this 

information collection which estimates 

that it takes 1 hour (for mandatory 

reporting) to complete this form for 

tobacco products for a total of 24 hours. 

Under § 1114.9 firms will prepare 

amendments to PMTA bundles in 

response to deficiency letters. These 

amendments contain additional 

information that we need to complete 

substantive review. We anticipate 2 

responses back per bundle and 

therefore, we estimate that 24 

respondents will submit 48 

amendments (24 × 2). Assuming 1,500 

hours as the time to prepare and submit 

a full PMTA and amendments may on 

average take 10 percent to 15 percent of 

that time (150–225). We averaged this 

time out (12.5 percent of a full 

submission preparation time) and 

arrived at 188 hours per response. FDA 

estimates the total burden hours for 

preparing amendments is 9,024 hours. 

Section § 1114.13 would allow an 

applicant to transfer ownership of a 

PMTA to a new owner. FDA believes 

this will be infrequent, so we have 

assigned 1 hour acknowledging the 

requirement. 

Section § 1114.15 is an alternative 

format of submitting a PMTA that meets 

the requirements of § 1114.7 that would 

reduce the burden associated with the 

submission and review of an 

application. Our estimated number of 2 

respondents is based on the number 

estimated for postmarket reports, which 

is 4 bundles (which is approximately 34 

products). Not all applicants will 

resubmit modifications to previously 

authorized products, so we estimate 2 

bundles (which is approximately 17 

products). FDA estimates further that a 

supplemental PMTA will take 25 

percent of the time it takes to do an 

original submission (including EA 

hours) for 428 hours per response. We 

estimate a total of 856 burden hours for 

this activity. 

Under § 1114.17 an applicant may 

submit a resubmission for the same 

tobacco product that received a 

marketing denial order or for a different 

new tobacco product that results from 

changes necessary to address the 

deficiencies outlined in a marketing 

denial order. We are estimating that out 

of all bundles received in 2020, 2021, 

and 2022, that an average of three 

bundles are authorized. If we receive 24 

bundles yearly, and based on historical 

data, 58 percent fail at acceptance 

(down to 8 bundles remaining), 17 

percent fail at filing (down to 7 bundles 

remaining), and 25 percent receive 

marketing orders (5 left). We estimate 

that 50 percent will try to resubmit in 

a year. Thus, this number of 

respondents is three (rounded up). FDA 

estimates that a resubmission will take 

33 percent of the time it takes to 

complete an original submission 

(including EA hours) at 565 hours per 

response for a total of 1,695 hours. 

An applicant is required to submit a 

PMTA and all supporting and related 

documents to FDA in electronic format 

that FDA can process, review, and 

archive unless an applicant requests, 

and FDA grants, a waiver from this 

requirement. FDA does not believe we 

will receive many waivers, so we have 

assigned one respondent to 

acknowledge the option to submit a 

waiver. Consistent with our other 

application estimates for waivers, we 

believe it would take .25 hours (15 

minutes) per waiver for a total of .25 

hours. 


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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1114.45; PMTA records ....................................................... 39 1 39 2 78 

1100.204; Pre-existing products records ............................. 1 1 1 2 2 

1107.3; Exemptions from Substantial Equivalence (SE) 

records .............................................................................. 1 1 1 2 2 

Total .............................................................................. ........................ ........................ ........................ ........................ 82 

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

Table 2 describes the annual 

recordkeeping burden. FDA estimates 

that 39 recordkeepers will maintain 

records at 2 hours per record. Included 

in this estimate are the 15 expected new 

recordkeepers of NTN products. Firms 

are also required to establish and 

maintain records related to SE 

exemption requests and pre-existing 

products (§ 1100.200 states that subpart 

C of part 1100). We expect the burden 

hours to be negligible for SE exemption 

requests. Firms would have already 

established the required records when 

submitting the SE exemption request. 

Similarly, we expect the hours of to be 

negligible for any pre-existing tobacco 

products that have already submitted 

standalone pre-existing tobacco product 

submissions, because firms would have 

established the required records when 

submitting the standalone pre-existing 

tobacco product submissions. We 

believe this time is usual and customary 

for these firms. We estimate that it 

would take 2 hours per record to 

establish the required records for a total 

of 4 hours. 

Based on the emergency approval by 

OMB our estimated burden for the 

information collection reflects an 

overall increase of 72 hours and a 

corresponding increase of 117 

responses/records. We attribute this 

adjustment to the addition of NTN 

product submissions. 

Dated: May 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10462 Filed 5–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4534] 

Reducing Microbial Food Safety 

Hazards in the Production of Seed for 

Sprouting; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for industry entitled 

‘‘Reducing Microbial Food Safety 

Hazards in the Production of Seed for 

Sprouting.’’ This final guidance is 

intended to inform the sprout seed 

industry (seed growers, conditioners, 

packers, holders, suppliers, and 

distributors) of FDA’s serious concern 

with the continuing outbreaks of 

foodborne illness associated with the 

consumption of raw and lightly cooked 

sprouts and provide FDA’s 

recommendations to firms throughout 

the production chain of seed for 

sprouting. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 16, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2018–D–4534 for ‘‘Reducing Microbial 

Food Safety Hazards in the Production 

of Seed for Sprouting: Guidance for 

Industry.’’ Received comments 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 


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