Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31327 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Pretest 1 and 2 screener ......................................... 3,600 1 1 0.08 (5 minutes) ........ 288 

Study 1 and 2 screener ........................................... 20,600 1 1 0.08 (5 minutes) ........ 1,648 

Pretest 1 ................................................................... 100 1 1 0.33 (20 minutes) ...... 33 

Main Study 1 ............................................................ 630 1 1 0.33 (20 minutes) ...... 208 

Pretest 2 ................................................................... 80 1 1 .33 (20 minutes) ........ 26 

Main Study 2 ............................................................ 400 1 1 0.33 (20 minutes) ...... 132 

Total .................................................................. ........................ ........................ ........................ .................................... 2,335 

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

References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES), and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. Beaver J.A., L.J. Howie L.J., L. Pelosof L, 

et al. ‘‘A 25-Year Experience of U.S. 

Food and Drug Administration 

Accelerated Approval of Malignant 

Hematology and Oncology Drugs and 

Biologics: A Review.’’ JAMA Oncology. 

2018; 4(6):849–856. doi:10.1001/ 

jamaoncol.2017.5618 

2. Sullivan H.W., A.C. O’Donoghue, K.T. 

David, N.J. Patel. ‘‘Disclosing 

Accelerated Approval on Direct-toConsumer Prescription Drug Websites.’’ 

Pharmacoepidemiology and Drug Safety. 

2018;27:1277–1280. https://doi.org/ 

10.1002/pds.4664 

Dated: June 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12264 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–2012–N–0369] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Regulations Under 

the Federal Import Milk Act 

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 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 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0212. 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. 

Regulations Under the Federal Import 

Milk Act (FIMA)—21 CFR Part 1210 

OMB Control Number 0910–0212— 

Extension 

This information collection supports 

FDA regulations. Under FIMA (21 

U.S.C. 141–149), milk or cream may be 

imported into the United States only by 

the holder of a valid import milk permit 

(21 U.S.C. 141). Before such permit is 

issued: (1) All cows from which import 

milk or cream is produced must be 

physically examined and found healthy; 

(2) if the milk or cream is imported raw, 

all such cows must pass a tuberculin 

test; (3) the dairy farm and each plant 

in which the milk or cream is processed 

or handled must be inspected and found 

to meet certain sanitary requirements; 

(4) bacterial counts of the milk at the 

time of importation must not exceed 

specified limits; and (5) the temperature 

of the milk or cream at time of 

importation must not exceed 50 °F (21 

U.S.C. 142). 

Our regulations in part 1210 (21 CFR 

part 1210) implement the provisions of 

FIMA. Sections 1210.11 and 1210.14 

require reports on the sanitary 

conditions of, respectively, dairy farms 

and plants producing milk and/or cream 

to be shipped to the United States. 

Section 1210.12 requires reports on the 

physical examination of herds, while 

§ 1210.13 requires the reporting of 

tuberculin testing of the herds. In 

addition, the regulations in part 1210 

require that dairy farmers and plants 

maintain pasteurization records 

(§ 1210.15) and that each container of 

milk or cream imported into the United 

States bear a tag with the product type, 

permit number, and shipper’s name and 


jbell on DSKJLSW7X2PROD with NOTICES
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