31328 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

address (§ 1210.22). Section 1210.20 

requires that an application for a permit 

to ship or transport milk or cream into 

the United States be made by the actual 

shipper. Section 1210.23 allows permits 

to be granted based on certificates from 

accredited officials. 

Description of Respondents: 

Respondents include foreign dairy farms 

and plants engaged in transporting milk 

and/or cream into the United States. 

Respondents are from the private sector 

(for-profit businesses). 

In the Federal Register of November 

4, 2020 (85 FR 70182), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 

section Form FDA No. Number of respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

1210.11 ........... 1996/Farm Inspection Report ................................. 1 200 200 1.5 ................................... 300 

1210.12 ........... 1995/Report of Physical Examination of Cows ...... 1 1 1 0.5 (30 minutes) ............. 0.5 

1210.13 ........... 1994/Report of Tuberculin Tests of Cattle ............. 1 1 1 0.5 (30 minutes) ............. 0.5 

1210.14 ........... 1997/Score Card for Sanitation Inspections of Milk 

Plants.

1 1 1 2 ...................................... 2 

1210.20 ........... 1993/Application for Permit to Ship or Transport 

Milk and/or Cream into United States.

1 1 1 0.5 (30 minutes) ............. 0.5 

1210.23 ........... 1815/Certificate/Transmittal for an Application ....... 1 1 1 0.5 (30 minutes) ............. 0.5 

Total ........ ................................................................................. ........................ ........................ ........................ ......................................... 304 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

1210.15 Pasteurization; Equipment and Methods ............................... 1 1 1 0.05 (3 minutes) ............. 0.05 

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

The Secretary of Health and Human 

Services has the discretion to allow 

Form FDA 1815, a duly certified 

statement signed by an accredited 

official of a foreign government, to be 

submitted in lieu of Forms FDA 1994 

and 1995. In the past, Form FDA 1815 

has been submitted in lieu of these 

forms. Because we have not received 

any Forms FDA 1994 or 1995 in the last 

3 years, we assume no more than 1 will 

be submitted annually. 

No burden has been estimated for the 

tagging requirement in § 1210.22 

because the information on the tag is 

either supplied by us (permit number) 

or is disclosed to third parties as a usual 

and customary part of the shipper’s 

normal business activities (type of 

product, shipper’s name and address). 

Under 5 CFR 1320.3(c)(2), the public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public is not subject to 

review by OMB under the PRA. Under 

5 CFR 1320.3(b)(2), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

business activities. 

Based on a review of the information 

collection since our last OMB approval, 

we have decreased our burden estimate. 

The estimated number of respondents 

and hours per response are based on our 

experience with the import milk permit 

program and the average number of 

import milk permit holders over the 

past 3 years. However, we have not 

received any responses in the last 3 

years. Therefore, we estimate that one or 

fewer to be submitted annually. 

Although we have not received any 

responses in the last 3 years, we believe 

these information collection provisions 

should be extended to provide for the 

potential future need for a milk 

importer. 

Dated: June 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12263 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0987] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for the Collection of Qualitative 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 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 July 12, 

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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31329 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0796. 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. 

Generic Clearance for the Collection of 

Qualitative Data on Tobacco Products 

and Communications 

OMB Control Number 0910–0796— 

Extension 

Under section 1003(d)(2)(D) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 393(d)(2)(D)), FDA is 

authorized to conduct educational and 

public information programs. 

In conducting studies relating to the 

regulation and communications related 

to tobacco products, FDA will need to 

employ formative qualitative research, 

including focus groups, usability 

testing, and/or indepth interviews (IDIs) 

to assess knowledge and perceptions 

about tobacco-related topics with 

specific target audiences. The 

information collected will serve three 

major purposes. First, formative 

research will provide critical knowledge 

about target audiences. FDA must first 

understand people’s knowledge and 

perceptions about tobacco-related topics 

prior to developing survey/research 

questions as well as stimuli for 

experimental studies. Second, by 

collecting communications usability 

information, FDA will be able to serve 

and respond to the ever-changing 

demands of consumers of tobacco 

products. Additionally, we will be able 

to determine the best way to present 

messages. Third, initial testing will 

allow FDA to assess consumer 

understanding of survey/research 

questions and study stimuli. Focus 

groups and/or IDIs with a sample of the 

target audience will allow FDA to refine 

the survey/research questions and study 

stimuli while they are still in the 

developmental stage. FDA will collect, 

and interpret information gathered 

through this generic clearance in order 

to: (1) Better understand characteristics 

of the target audience—its perceptions, 

knowledge, attitudes, beliefs, and 

behaviors—and use these in the 

development of appropriate survey/ 

research questions, study stimuli, or 

communications; (2) more efficiently 

and effectively design survey/research 

questions and study stimuli; and (3) 

more efficiently and effectively design 

experimental studies. 

FDA is requesting approval of an 

extension of this generic clearance for 

collecting information using qualitative 

methods (i.e., individual interviews, 

small group discussions, and focus 

groups) for studies involving all tobacco 

products regulated by FDA. This 

information will be used as a first step 

to explore concepts of interest and assist 

in the development of quantitative 

study proposals, complementing other 

important research efforts in the 

Agency. This information may also be 

used to help identify and develop 

communication messages, which may 

be used in education campaigns. Focus 

groups play an important role in 

gathering information because they 

allow for an indepth understanding of 

individuals’ attitudes, beliefs, 

motivations, and feelings. Focus group 

research serves the narrowly defined 

need for direct and informal public 

opinion on a specific topic. 

The number of respondents to be 

included in each new pretest may vary, 

depending on the nature of the material 

or message being tested and the target 

audience. Table 1 provides examples of 

the types of studies that may be 

administered and estimated burden 

levels during the 3-year period. Time to 

read, view, or listen to the message 

being tested is built into the ‘‘Hours per 

Response’’ figures. Our estimated 

burden for the information collection 

reflects an overall increase of 5,641 

hours and a corresponding increase of 

16,585 responses. We attribute this 

adjustment to the number of study 

responses used during the current 

approval and now estimated for the next 

3 years. 

In the Federal Register of September 

29, 2020 (85 FR 60999), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two 

comments; however, only one was PRArelated. 

(Comment) The comment expressed 

support for FDA’s collection of 

qualitative research on tobacco 

products. The comment stated further 

that while FDA indicates that this 

research will meet the ‘‘narrowly 

defined need for direct and informal 

public opinion on a specific topic,’’ the 

Agency has recently used this work for 

broader purposes, including informing 

the Proposed Rule for graphic health 

warnings.’’ 

(Response) FDA appreciates the 

support for conducting qualitative 

research on tobacco products. FDA 

disagrees with the comment suggesting 

that the Agency has used its qualitative 

generic collection for ‘‘broader 

purposes’’ than contemplated by the 

generic collection. Review of a generic 

collection occurs in two stages: (1) A 

full PRA review of the generic clearance 

ICR, which includes the general 

approach and methodology, at least 

once every 3 years and (2) an expedited 

review of the individual collections that 

fall within the scope of the generic 

clearance. OMB reviewed the individual 

collection[s] that this comment cites and 

approved the collection, having 

determined that it was appropriately 

within the scope of the generic 

clearance. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of interview Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

In-Person Individual IDIs ...................................................................... 1,092 1 1,092 1 ...................................... 1,092 

IDI Screener ......................................................................................... 1,800 1 1,800 0.083 (5 minutes) ........... 150 

Focus Group Screener ........................................................................ 19,385 1 19,385 0.25 (15 minutes) ........... 4,846 

Focus Group Interviews ....................................................................... 5,897 1 5,897 1.5 ................................... 8,846 

Total .............................................................................................. ........................ ........................ ........................ ......................................... 14,934 

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


jbell on DSKJLSW7X2PROD with NOTICES
31330 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

Dated: June 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12256 Filed 6–10–21; 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 June 25, 2021. The purpose 

of this meeting is to consider interim 

recommendations addressing the 

inequities and the impact of longCOVID or Post-Acute Sequelae of 

SARS–CoV–2 infection (PASC), and 

access to personal protection 

equipment, testing, and therapeutics 

that are related to this pandemic. 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, June 25, 2021, from 2 

p.m. to approximately 6 p.m. ET (date 

and time are tentative and subject to 

change). The confirmed time and 

agenda will be posted on the COVID–19 

Health Equity Task Force web page: 

www.minorityhealth.hhs.gov/ 

healthequitytaskforce/ when this 

information becomes available. 

FOR FURTHER INFORMATION CONTACT: 

Samuel Wu, Designated Federal Officer 

for the Task Force; Office of Minority 

Health, Department of Health and 

Human Services, Tower Building, 1101 

Wootton Parkway, Suite 100, Rockville, 

Maryland 20852. Phone: 240–453–6160; 

email: COVID19HETF@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The COVID–19 Health 

Equity Task Force (Task Force) was 

established by Executive Order 13995, 

dated January 21, 2021. The Task Force 

is tasked with providing specific 

recommendations to the President, 

through the Coordinator of the COVID– 

19 Response and Counselor to the 

President (COVID–19 Response 

Coordinator), for mitigating the health 

inequities caused or exacerbated by the 

COVID–19 pandemic and for preventing 

such inequities in the future. The Task 

Force shall submit a final report to the 

COVID–19 Response Coordinator 

addressing any ongoing health 

inequities faced by COVID–19 survivors 

that may merit a public health response, 

describing the factors that contributed to 

disparities in COVID–19 outcomes, and 

recommending actions to combat such 

disparities in future pandemic 

responses. 

The meeting is open to the public and 

will be live-streamed at www.hhs.gov/ 

live. No registration is required. A 

public comment session will be held 

during the meeting. Pre-registration is 

required to provide public comment 

during the meeting. To pre-register, 

please send an email to 

COVID19HETF@hhs.gov and include 

your name, title, and organization by 

close of business on Friday, June 18, 

2021. Comments will be limited to no 

more than three minutes per speaker 

and should be pertinent to the meeting 

discussion. Individuals are encouraged 

to provide a written statement of any 

public comment(s) for accurate minutetaking purposes. If you decide you 

would like to provide public comment 

but do not pre-register, you may submit 

your written statement by emailing 

COVID19HETF@hhs.gov no later than 

close of business on Thursday, July 1, 

2021. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

contact: COVID19HETF@hhs.gov and 

reference this meeting. Requests for 

special accommodations should be 

made at least 10 business days prior to 

the meeting. 

Dated: June 8, 2021. 

Samuel Wu, 

Designated Federal Officer, COVID–19 Health 

Equity Task Force. 

[FR Doc. 2021–12320 Filed 6–10–21; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 

Nursing Research Initial Review Group. 

Date: June 24–25, 2021. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Nursing 

Research, 6701 Democracy Boulevard, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Cheryl Nordstrom, Ph.D., 

Scientific Review Officer, National Institute 

of Nursing Research, National Institutes of 

Health, 6701 Democracy Blvd., Suite 703H, 

Bethesda, MD 20892, (301) 827–1499, 

cheryl.nordstrom@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: June 7, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–12234 Filed 6–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 on 

Aging Special Emphasis Panel; Multi-Omics 

Studies for Osteoporosis. 

Date: July 9, 2021. 

Time: 12:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 


jbell on DSKJLSW7X2PROD with NOTICES