Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 31155 

in the body of your comments and you 

must identify the 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Lauren D. Tesh, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

AMDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

new drug application (NDA) 207356, 

amikacin liposome inhalation 

suspension, sponsored by Insmed, Inc., 

for the proposed indication of treatment 

of nontuberculous mycobacterial lung 

disease caused by Mycobacterium 

avium complex in adults as part of a 

combination antibacterial drug regimen. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Dockets Management Staff (see the 

ADDRESSES section) on or before July 24, 

2018, will be provided to the committee. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 16, 2018. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 17, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Lauren Tesh 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: June 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14240 Filed 7–2–18; 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) 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 

(PRA). 

DATES: Fax written comments on the 

collection of information by August 2, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0212. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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 

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 


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31156 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 

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 

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. 

In the Federal Register of April 2, 

2018 (83 FR 13992), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate 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/Sanitary inspection of dairy farms ...... 2 200 400 1.5 ......................... 600 

1210.12 .......... 1995/Physical examination of cows ............. 1 1 1 0.5 (30 minutes) .... 0.5 

1210.13 .......... 1994/Tuberculin test .................................... 1 1 1 0.5 (30 minutes) .... 0.5 

1210.14 .......... 1997/Sanitary inspections of plants ............. 2 1 2 2 ............................ 4 

1210.20 .......... 1993/Application for permit .......................... 2 1 2 0.5 (30 minutes) .... 1 

1210.23 .......... 1815/Permits granted on certificates ........... 2 1 2 0.5 (30 minutes) .... 1 

Total ........ ...................................................................... ........................ ........................ ........................ ............................... 607 

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 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1210.15 .......... 2 1 2 0.05 (3 minutes) ............................................................. 0.10 (6 minutes). 

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

Upon review of the information 

collection, we have retained the 

currently approved estimated burden. 

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. Assuming two respondents 

will submit approximately 200 Form 

FDA 1996 reports annually for a total of 

600 responses, and that each response 

requires 1.5 hours, we estimate the total 

burden is 600 hours. 

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. To date, 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 one will 

be submitted annually. We also assume 

each submission requires 0.5 hour for a 

total of 0.5 burden hour annually. 

We estimate that two respondents will 

submit one Form FDA 1997 report 

annually, for a total of two responses. 

We estimate the reporting burden to be 

2 hours per response, for a total burden 

of 4 hours. 

We estimate that two respondents will 

submit one Form FDA 1993 report 

annually, for a total of two responses. 

We estimate the reporting burden to be 

0.5 hour per response, for a total burden 

of 1 hour. 

We estimate that two respondents will 

submit one Form FDA 1815 report 

annually, for a total of two responses. 

We estimate the reporting burden to be 

0.5 hour per response, for a total burden 

of 1 hour. 

With regard to records maintenance, 

we estimate that approximately two 

recordkeepers will spend 0.05 hour 

annually maintaining the additional 

pasteurization records required by 

§ 1210.15, for a total of 0.10 hour 

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. 

Dated: June 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14266 Filed 7–2–18; 8:45 am] 

BILLING CODE 4164–01–P 


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