Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40855 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Awardee activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

Records related to Initial Report ....... 400 1 400 0.5 hour (30 minutes) ....................... 200 

Records related to Progress Reports 400 2 800 0.5 hour (30 minutes) ....................... 400 

Records related to Supplement or 

Followup Report (if applicable).

100 1 100 0.5 hour (30 minutes) ....................... 50 

Total ........................................... ........................ ........................ ........................ ........................................................... 650 

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

Recordkeeping activities include 

storing and maintaining records related 

to submitting a request to participate in 

the project and compiling reports. 

Respondents should use current record 

retention capabilities for electronic or 

paper storage to achieve these activities. 

We assume it will take 0.5 hour/year to 

ensure the documents related to 

submitting a request to participate in the 

program are retained properly according 

to their existing recordkeeping policies, 

but no less than 3 years, as 

recommended by FDA (table 2). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Awardee activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Coordination with partnering entities related to Initial Report ................................................................................... 300 2 600 8 4,800 

Coordination with partnering entities related to Progress 

Reports ............................................................................. 300 4 1,200 8 9,600 

Coordination with partnering entities related to Supplement 

or Followup Report (if applicable) .................................... 100 2 200 8 1,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,000 

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

For those pilot projects that involve a 

participant composed of partnering 

entities in the program, FDA is taking 

into consideration the time that 

partnering entities will spend 

coordinating with each other in a pilot 

project. We estimate that 300 

respondents will work with their 

respective partnering entities and the 

average number of partnering entities 

will be 2. We assume each respondent 

will spend 8 hours coordinating with 

each partnering entity on each response 

for this pilot. We estimate that seven 

respondents will need to coordinate 

with an average of two partnering 

entities to create progress reports and 

the final report to submit to FDA (table 

3). 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16192 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Study Data Submission; 

Data Standards; Technical Rejection 

Criteria for Study Data Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing the effective date for 

Electronic Common Technical 

Document (eCTD) validations 

referenced in FDA’s ‘‘Technical 

Rejection Criteria for Study Data’’ (TRC). 

DATES: The eCTD validations will 

become applicable on September 15, 

2021. 

ADDRESSES: You may submit either 

electronic or written comments 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’’). 


jbell on DSKJLSW7X2PROD with NOTICES
40856 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

1Under section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 

379k–1(a)), at least 24 months after the issuance of 

a final guidance document in which FDA has 

specified the electronic format for submitting 

certain submission types to the Agency, such 

content must be submitted electronically and in the 

format specified by FDA. 

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–1216 for ‘‘Electronic Study Data 

Submission; Data Standards; Technical 

Rejection Criteria for Study Data 

Effective Date.’’ 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.’’ 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: 

Jonathan Resnick, Center for Drug 

Evaluation and Research (CDER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3160, 

Silver Spring, MD 20993–0002, 301– 

796–7997, Jonathan.Resnick@

fda.hhs.gov, or Stephen Ripley, Center 

for Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 7301, Silver Spring, MD 20993– 

0002, 240–402–7911, Stephen.Ripley@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with the guidance 1 for 

industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data,’’ submissions 

that are not submitted electronically and 

electronic submissions that are not in a 

format that FDA can process, review, 

and archive will not be filed or received, 

unless they have an exemption or 

waiver from the electronic submission 

requirements. The Agency can process, 

review, and archive electronic 

submissions of study data that use the 

standards specified in the Data 

Standards Catalog posted to FDA’s 

Study Data Standards Resources web 

page (https://www.fda.gov/industry/fdaresources-data-standards/study-datastandards-resources). 

The technical rejection criteria are 

automated validations by the CDER or 

CBER inbound processing system using 

the specifications set forth in FDA’s 

‘‘Specifications for eCTD Validation 

Criteria’’ to determine compliance with 

the requirement to submit electronic 

standardized study data. The eCTD 

validations referenced in FDA’s TRC 

will become effective on September 15, 

2021. Starting September 15, 2021, FDA 

will reject submissions that contain any 

high validation errors included in the 

TRC. The latest version of the TRC is 

available on FDA’s web page on Study 

Data for Submission to CDER and CBER 

(https://www.fda.gov/industry/studydata-standards-resources/study-datasubmission-cder-and-cber). 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16187 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0547] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey on the 

Occurrence of Foodborne Illness Risk 

Factors in Selected Retail and 

Foodservice Facility Types 

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 August 30, 

2021. 

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 0910–0744. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 


jbell on DSKJLSW7X2PROD with NOTICES