12952 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 

‘‘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: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, 240–402–6511, email: 

cderdatastandards@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA’s 

CDER is issuing this Federal Register 

notice to announce the date that support 

will begin for version 1.1 of the CDISC 

SENDIG–DART and version 1.6 of the 

CDISC SDTM and the dates when such 

new standard and version update will 

be required in certain submissions. The 

FDA guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Standardized Study Data’’ 

(October 2020) (eStudy Data guidance), 

posted on FDA’s Study Data Standards 

Resources web page at https://

www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm, implements the electronic 

submission requirements of section 

745A(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379k–1(a)) for 

study data contained in NDAs, ANDAs, 

certain BLAs, and certain INDs 

submitted to CDER or the Center for 

Biologics Evaluation and Research by 

specifying the format for electronic 

submissions. The eStudy Data guidance 

states that a Federal Register notice will 

specify any new standards and version 

updates to FDA-supported study data 

standards that will be added to the 

Catalog, when the support for such 

standards and version updates begins or 

ends, and when the requirement to use 

such standards and version updates in 

submissions begins or ends. 

Support for version 1.1 of the CDISC 

SENDIG–DART and version 1.6 of the 

CDISC SDTM will begin on March 15, 

2021, the transition date. The 

requirement for electronic submissions 

to be submitted using version 1.1 of the 

CDISC SENDIG–DART will begin March 

15, 2023, for NDAs, ANDAs and certain 

BLAs, and March 15, 2024, for certain 

INDs. The requirement for electronic 

submissions to be submitted using 

version 1.6 of the CDISC SDTM will 

begin on March 15, 2022. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04609 Filed 3–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0180] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for the Collection of Quantitative Data 

on Tobacco Products and 

Communications 

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 the generic 

clearance for the collection of 

quantitative data on tobacco products 

and communications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 4, 2021. 

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 May 4, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 4, 2021. 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– 

2018–N–0180 for ‘‘Generic Clearance for 

the Collection of Quantitative Data on 

Tobacco Products and 

Communications.’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 12953 

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: 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: 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. 

Generic Clearance for the Collection of 

Quantitative Data on Tobacco Products 

and Communications 

OMB Control Number 0910–0810— 

Extension 

To conduct educational and public 

information programs relating to 

tobacco use as authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA’s Center for Tobacco 

Products will conduct research and use 

a variety of media to inform and educate 

the public, tobacco retailers, and health 

professionals about the health risks of 

tobacco use, how to quit using tobacco 

products, and FDA’s role in regulating 

tobacco. 

To ensure that these educational and 

public information programs have the 

highest potential to be received, 

understood, and accepted by those for 

whom they are intended, the Center for 

Tobacco Products will conduct research 

and develop health messages relating to 

the control and prevention of disease. In 

conducting such research, FDA will use 

quantitative methods (i.e., surveys, 

experimental studies) for studies about 

tobacco products. These studies may be 

used to collect information related to 

the formative pretesting of tobacco 

communication messages and other 

materials directed at consumers. This 

type of research involves: (1) Assessing 

audience knowledge, attitudes, 

behaviors, and other characteristics for 

the purpose of determining the need for 

and developing health messages, 

communication strategies, and public 

information programs; (2) pretesting 

these health messages, strategies, and 

program components while they are in 

developmental form to assess audience 

comprehension, reactions, and 

perceptions; and (3) adding to the 

regulatory science knowledge base. 

Quantitative studies play an important 

role in exploring areas of research and 

gathering information because they can 

be used to summarize a population of 

interest on key variables or reveal 

systematic relationships between 

variables. 

Formative pretesting is a staple of best 

practices in communications research. 

Obtaining voluntary feedback from 

intended audiences during the 

development of messages and materials 

is crucial for the success of every 

communication program. The purpose 

of obtaining information from formative 

pretesting is that it allows FDA to 

improve materials and strategies while 

revisions are still affordable and 

possible. Formative pretesting can also 

avoid potentially expensive and 

dangerous unintended outcomes caused 

by audiences interpreting messages in a 

way that was not intended by the 

drafters. By maximizing the 

effectiveness of messages and strategies 

for reaching targeted audiences, the 

frequency with which tobacco 

communication messages need to be 

modified should be greatly reduced. 

The voluntary information collected 

will serve the primary purpose of 

providing FDA information about the 

perceived effectiveness of messages, 

advertisements, and materials in 

reaching and successfully 

communicating with their intended 

audiences. Quantitative testing 

messages and other materials with a 

sample of the target audience will allow 

FDA to refine messages, advertisements, 

and materials, including questionnaires 

or images, directed at consumers while 

the materials are still in the 

developmental stage. 

In addition, quantitative information 

is needed by FDA to track changes in 

response to policy and regulatory 

actions and to expand the tobacco 

regulatory science base by providing 

information on behavior, knowledge, 

and attitudes about tobacco products, 

including postmarketing surveillance of 

tobacco products. 

FDA estimates the burden of this 

collection of information as follows: 


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12954 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity 

Number 

of 

respondents 

Number 

of responses 

per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Screener .............................................................. 485,580 1 485,580 0.083 (5 minutes) ........... 40,465 

Self-Administered Surveys .................................. 133,728 1 133,728 0.33 (20 minutes) ........... 44,576 

Total ............................................................. ........................ ........................ ........................ ........................................ 85,041 

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

Number of respondents to be included 

in each new survey will vary, 

depending on the nature of the material 

or message being tested and the target 

audience. Table 1 provides examples of 

the types of activities that may be 

administered and estimated burden 

levels during the 3-year period. Time to 

read, review, or complete the activity is 

built into the ‘‘Average Burden per 

Response’’ figures. Our estimated 

burden for the information collection 

reflects an overall increase of 60,000 

hours and a corresponding increase of 

461,808 responses. We attribute the 

adjustment to an increase in the number 

of new quantitative studies that are 

anticipated underneath this information 

collection during the next 3 years 

(proposed extension). 

Dated: March 1, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04606 Filed 3–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–P–1189] 

Canned Tuna Deviating From the 

Standard of Identity; Amendment of 

Temporary Marketing Permit 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending StarKist Seafood Company’s 

temporary permit to market test canned 

tuna. The temporary permit is amended 

to add three additional manufacturing 

locations and to increase the amount of 

test product. This amendment will 

allow the applicant to continue to test 

market the test product and collect data 

on consumer acceptance of the test 

product. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

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

2371. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 20, 2014 (79 FR 

35362), we issued a notice announcing 

that we had issued a temporary permit 

to StarKist Seafood Company, 225 North 

Shore Dr., Pittsburgh, PA 15212, to 

market test products identified as 

canned tuna products. The permit 

allowed for the test product to be 

manufactured at Galapesca S.A., Km. 

12.5 Via A Duale, Guayaquil, Ecuador, 

and StarKist Samoa Co., 368 Atu’u Rd., 

Pago Pago, American Samoa 96799. We 

issued the permit to facilitate market 

testing of products that deviate from the 

requirements of the standard of identity 

for canned tuna in 21 CFR 161.190, 

which was issued under section 401 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 341). 

In the Federal Register of March 7, 

2016 (81 FR 11813), we issued a notice 

announcing that we were extending the 

temporary market permit issued to 

StarKist Seafood Company. The 

extension allows the applicants to 

continue to measure consumer 

acceptance of the products and assess 

the commercial feasibility of the 

products, in support of a petition to 

amend the standard of identity for 

canned tuna. The new expiration date of 

the permit will be either the effective 

date of a final rule amending the 

standard of identity for canned tuna that 

may result from the petition or 30 days 

after denial of the petition. 

Under our regulations at 21 CFR 

130.17(f), we are amending the 

temporary permit issued to StarKist 

Seafood Company, to allow the test 

product to be manufactured at three 

additional plants: Tropical Canning 

(Thailand) Public Co., LTD., 1⁄1 M.2 

T.Thungyai, Hatyai, Songkhla 90110, 

Thailand; ISA Value Co., Ltd., 44/4 

Moo1, Petchkasem Road, Yaicha, 

Sampran, Nakornpathom 73110, 

Thailand; and Tri-Marine (Solomon 

Islands), Soltuna Ltd., 1 Tuna Dr., Noro, 

Western Province, Solomon Islands. We 

are also amending the temporary permit 

to increase the amount of test product 

to be market tested to 213,500,000 

pounds (96,841,971 kilograms) in retail 

cans of various sizes. All other 

conditions and terms of this permit 

remain the same. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04607 Filed 3–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the COVID–19 Health Equity 

Task Force 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As required by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the COVID–19 Health Equity Task 

Force (Task Force) will hold a virtual 

meeting on March 26, 2021. The 

purpose of this meeting is to discuss 

equitable vaccine access and 

acceptance. This meeting is open to the 

public and will be live-streamed at 

www.hhs.gov/live. Information about the 

meeting will be posted on the HHS 

Office of Minority Health website: 

www.minorityhealth.hhs.gov/ 

healthequitytaskforce/ prior to the 

meeting. 

DATES: The Task Force meeting will be 

held on Friday, March 26, 2021, from 

approximately 12 p.m. to 3 p.m. ET 

(times are tentative and subject to 

change). The confirmed time and 

agenda will be posted on the COVID–19 

Health Equity Task Force website: 

www.minorityhealth.hhs.gov/ 


jbell on DSKJLSW7X2PROD with NOTICES