Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Notices 29753 

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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29754 Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Notices 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Food Safety, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Homola, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1700; 

or Lauren Kleinman, Center for Food 

Safety and Applied Nutrition, Office of 

Regulations and Policy (HFS–024), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Reducing Microbial Food Safety 

Hazards in the Production of Seed for 

Sprouting.’’ This guidance is intended 

to inform the sprout seed industry (seed 

growers, conditioners, packers, holders, 

suppliers, and distributors) of our 

serious concern with the continuing 

outbreaks of foodborne illness 

associated with the consumption of raw 

and lightly cooked sprouts and provide 

our recommendations to firms 

throughout the production chain of seed 

for sprouting. We are issuing the 

guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The guidance represents the 

current thinking of FDA on this topic. 

It does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

In the Federal Register of June 25, 

2019 (84 FR 29867), we announced a 

draft guidance for industry and gave 

interested parties an opportunity to 

submit comments by August 26, 2019, 

for us to consider before beginning work 

on the final version of the guidance. We 

received 10 comments on the draft 

guidance and have modified the final 

guidance where appropriate. Changes to 

the guidance include the addition of 

examples, information about the scope 

of recommendations pertaining to 

cleaning and sanitizing of wet and dry 

food contact surfaces, information about 

testing seed for sprouting, research 

related to the source of contamination in 

sprout-related outbreaks, and updated 

recommendations related to proximity 

of seed growing operations to a 

domestic animal raising farm. The 

guidance announced in this notice 

finalizes the draft guidance dated June 

2019. 

II. Paperwork Reduction Act of 1995 

This guidance contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3521) is not 

required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: May 6, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10189 Filed 5–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; NIAMS 

AMSC Member Conflict Review Meeting. 

Date: June 13, 2022. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Arthritis, 

Musculoskeletal and Skin Diseases, 6701 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Marisol Espinoza-Pintucci, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of 

Arthritis, Musculoskeletal and Skin Diseases, 

NIH, 6701 Democracy Boulevard, Suite 800, 

Plaza One, Bethesda, MD 20817, 301–827– 

6959, marisol.espinoza-pintucci@nih.gov. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; NIAMS 

AMS Member Conflict Review. 

Date: June 14, 2022. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Arthritis and 

Musculoskeletal and Skin Diseases, 6701 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Marisol Espinoza-Pintucci, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of 

Arthritis, Musculoskeletal and Skin Diseases, 

NIH, 6701 Democracy Boulevard, Suite 800, 

Plaza One, Bethesda, MD 20817, 301–827– 

6959, marisol.espinoza-pintucci@nih.gov. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 


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