Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices 29267 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–D–0242, FDA– 

2021–D–0243, FDA–2021–D–0244, and FDA– 

2021–D–0245] 

Compliance Policy Guide Sec. 555.400 

Aflatoxins in Human Food; Compliance 

Policy Guide Sec. 570.200 Aflatoxins in 

Brazil Nuts; Compliance Policy Guide 

Sec. 570.375 Aflatoxins in Peanuts and 

Peanut Products; and Compliance 

Policy Guide Sec. 570.500 Aflatoxins in 

Pistachio Nuts; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of four final 

Compliance Policy Guides (CPG) 

entitled ‘‘Compliance Policy Guide Sec. 

555.400 Aflatoxins in Human Food,’’ 

‘‘Compliance Policy Guide Sec. 570.200 

Aflatoxins in Brazil Nuts,’’ ‘‘Compliance 

Policy Guide Sec. 570.375 Aflatoxins in 

Peanuts and Peanut Products,’’ and 

‘‘Compliance Policy Guide Sec. 570.500 

Aflatoxins in Pistachio Nuts.’’ These 

CPGs revise the existing CPGs by 

updating the format and including 

references to other aflatoxins CPGs and 

a reference to the Memorandum of 

Understanding between the Agricultural 

Marketing Service (AMS) of the U.S. 

Department of Agriculture (USDA) and 

FDA. The CPGs provide guidance for 

FDA staff on FDA’s current regulatory 

criteria for aflatoxins in human food, 

Brazil nuts, peanuts and peanut 

products, and pistachio nuts. 

DATES: The announcement of the 

guidances is published in the Federal 

Register on June 1, 2021. 

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 Docket No. FDA–2021–D– 

0242 for ‘‘Compliance Policy Guide Sec. 

555.400 Aflatoxins in Human Food,’’ 

Docket No. FDA–2021–D–0243 for 

‘‘Compliance Policy Guide Sec. 570.200 

Aflatoxins in Brazil Nuts,’’ Docket No. 

FDA–2021–D–0244 for ‘‘Compliance 

Policy Guide Sec. 570.375 Aflatoxins in 

Peanuts and Peanut Products,’’ and 

Docket No. FDA–2021–D–0245 for 

‘‘Compliance Policy Guide Sec. 570.500 

Aflatoxins in Pistachio Nuts.’’ 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 

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 guidances to the Office of 

Strategic Planning and Operational 

Policy, Office of Regulatory Affairs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4337, Silver Spring, MD 20993. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidances. 

FOR FURTHER INFORMATION CONTACT: 

Mischelle Ledet, Office of Compliance, 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–701–5986. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

four CPGs for FDA staff entitled 

‘‘Compliance Policy Guide Sec. 555.400 

Aflatoxins in Human Food,’’ 

‘‘Compliance Policy Guide Sec. 570.200 

Aflatoxins in Brazil Nuts,’’ ‘‘Compliance 

Policy Guide Sec. 570.375 Aflatoxins in 

Peanuts and Peanut Products,’’ and 

‘‘Compliance Policy Guide Sec. 570.500 

Aflatoxins in Pistachio Nuts.’’ We are 

issuing these guidances consistent with 

our good guidance practices regulation 

(21 CFR 10.115). We are issuing these 

four CPGs as final and without first 

providing an opportunity to comment 


jbell on DSKJLSW7X2PROD with NOTICES
29268 Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices 

because the revisions are nonsubstantive; for example, we revised the 

CPGs’ formats to be consistent with 

other CPGs, included references to other 

aflatoxins CPGs, and included a 

reference to the Memorandum of 

Understanding between USDA/AMS 

and FDA. Given the minor nature of 

these revisions, an opportunity for 

public comment before we finalize the 

CPGs is unnecessary. However, as is the 

case for all guidance documents, the 

public may comment on any guidance 

document at any time (§ 10.115(g)(5)). 

The guidances represent the current 

thinking of FDA on this topic. They do 

not establish any rights for any person 

and are not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

These four CPGs update the 

previously issued ‘‘CPG Sec. 555.400 

Foods—Adulteration with Aflatoxin,’’ 

‘‘CPG Sec. 570.200 Brazil Nuts— 

Adulteration with Aflatoxin,’’ ‘‘CPG 

Sec. 570.375 Aflatoxin in Peanuts and 

Peanut Products,’’ and ‘‘CPG Sec. 

570.500 Pistachio Nuts—Aflatoxin 

Adulteration.’’ The CPGs are intended 

to provide guidance for FDA staff 

regarding adulteration in human food, 

Brazil nuts, peanuts and peanut 

products, and pistachio nuts due to the 

presence of aflatoxins and explain when 

we may consider such foods to be 

adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 342). 

II. Paperwork Reduction Act of 1995 

These guidances contain no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidances at either 

https://www.fda.gov/FoodGuidances or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidances. 

Dated: May 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11388 Filed 5–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–new] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before July 1, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–New–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Advancing the 

response to COVID–19 Learning 

Community Measure. 

Type of Collection: New. 

OMB No. 0990–NEW—Office within 

OS—OMH 

Abstract: The Department of Health 

and Human Services, Office of Minority 

Health (OMH) is seeking an approval by 

OMB on a new information collection, 

Advancing the response to COVID–19 

Learning Community Measure (hereafter 

COVID–19 Learning Community 

Measure). The purpose of this data 

collection is to gather quantitative and 

qualitative data from Learning 

Community members to monitor 

learning community performance in 

achieving process and outcome 

measures over the course of the one-year 

project. OMH will collect a set of 

process and outcome measures from 

program participants to assess the 

degree to which the learning community 

is effective in connecting subject matter 

experts and public health leaders, 

facilitating networking, and peer-to-peer 

information sharing of promising 

practices, programs, and/or policy. 

The OMB clearance will enable OMH 

to monitor and evaluate the COVID–19 

Learning Community performance. The 

data will be used to report the impact 

of the COVID–19 Learning Community. 

The ability to monitor and evaluate 

performance in this manner, and to 

work towards continuous program 

improvement are basic functions that 

OMH must be able to accomplish in 

order to carry out goals for the COVID– 

19 Learning Community and to ensure 

the most effective and appropriate use 

of resources. 

Likely Respondents: Members and 

staff from academia, community 

organizations, local/state/federal 

government, private sector, and tribal 

government and services who serve 

American Indian and Alaska Native 

and/or racial and ethnic minorities. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

COVID–19 Learning Community Members ..................................................... 200 1 5/60 17 

Total .......................................................................................................... ........................ ........................ ........................ 17 


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