46074 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0192] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishing and 

Maintaining Lists of U.S. Milk Product 

Manufacturers/Processors With 

Interest in Exporting 

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. 

DATES: Fax written comments on the 

collection of information by November 

2, 2017. 

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 0910–0509. 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. 

Establishing and Maintaining Lists of 

U.S. Milk Product Manufacturers/ 

Processors With Interest in Exporting— 

21 U.S.C. 371 

OMB Control Number 0910–0509— 

Extension 

The United States exports a large 

volume and variety of foods in 

international trade. For certain food 

products, foreign governments may 

require assurances from the responsible 

authority of the country of origin of an 

imported food that the processor of the 

food is in compliance with applicable 

country of origin regulatory 

requirements. With regard to U.S. milk 

products, FDA is the competent U.S. 

food safety authority to provide this 

information to foreign governments. 

FDA provides the requested information 

about processors in the form of lists, 

which are provided to the foreign 

governments and posted online at 

https://www.fda.gov/Food/ 

GuidanceRegulation/ImportsExports/ 

Exporting/default.htm. 

Currently, FDA provides Chile, China, 

and the European Union (EU) with a list 

of U.S. milk product manufacturers/ 

processors that: (1) Have expressed 

interest in exporting their products to 

these countries; (2) are subject to FDA’s 

jurisdiction; and (3) are not the subject 

of a pending enforcement action (i.e., an 

injunction or seizure or a pending 

warning letter). 

FDA has published guidance 

documents for these countries under the 

authority of section 701(h) of the 

Federal, Food, Drug, and Cosmetic Act 

(21 U.S.C. 371(h)), which authorizes the 

Secretary of Health and Human Services 

(the Secretary) to develop guidance 

documents with public participation 

presenting the views of the Secretary on 

matters under the jurisdiction of FDA. 

The guidance documents explain 

what information manufacturers/ 

processors should submit to FDA to be 

considered for inclusion on the lists and 

what criteria FDA intends to use to 

determine eligibility for placement on 

the lists. The guidance documents also 

explain how FDA intends to update the 

list and communicate any new 

information to the government that 

requested the list. Finally, the guidance 

documents note that the information is 

provided voluntarily by manufacturers/ 

processors with the understanding that 

it will be posted on FDA’s external Web 

site and communicated to, and possibly 

further disseminated by, the government 

that requested the list; thus, FDA 

considers the information on the lists to 

be information that is not protected 

from disclosure under 5 U.S.C. 

552(b)(4). 

Application for inclusion on each list 

is voluntary. However, some foreign 

governments may require inclusion on 

the list for acceptance of imported food. 

FDA recommends that U.S. 

manufacturers/processors that want to 

be placed on the export lists send FDA 

the following information: (1) Country 

to which the milk manufacturer/ 

processor wants to export product; (2) 

type of milk product facility; (3) the 

Food Facility Registration Module 

number (the information collected by 

this module is approved under OMB 

control number 0910–0502); (4) name 

and address of the firm and the 

manufacturing plant; (5) name, 

telephone number, and email address of 

the contact person; (6) list of products 

divided into three categories: Presently 

shipped, ready to ship, and available for 

shipment in the next 3 years; (7) 

identities of Agencies that inspected the 

plant; (8) date of last inspection, plant 

number, and copy of last inspection 

notice; and (9) if other than an FDA 

inspection, copy of last inspection 

report. 

We request that this information be 

updated every 2 years. 

We use the information submitted by 

firms to determine their eligibility for 

placement on the export lists, which are 

published on our Web site. The purpose 

of the lists is to help foreign 

governments in their determinations of 

which U.S. milk product manufacturers 

and processors are eligible to export to 

their respective countries. 

FDA has recently developed an 

electronic registry system (Form FDA 

3972) that allows milk product 

manufacturers and processors to 

electronically send a request to FDA to 

be included on the export lists. 

Manufacturers and processors that 

prefer to submit a paper request in a 

format of their own choosing will still 

have the option to do so. Electronic 

Form FDA 3972 collects the same 

information as is currently collected via 

the existing paper-based process. Draft 

screenshots of Form FDA 3972 and 

instructions are available at https://

www.fda.gov/Food/ 

GuidanceRegulation/ImportsExports/ 

Exporting/ucm496929.htm and is 

entitled ‘‘Dairy Listing Module.’’ 

Description of Respondents: 

Respondents to this collection of 

information include U.S. milk product 

manufacturers/processors subject to 

FDA jurisdiction that wish to export to 

certain foreign countries that require 

inclusion on export lists. 

In the Federal Register of June 15, 

2017 (82 FR 27485), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received three 

comments, however, they were not 

responsive to the four collection of 

information topics solicited and 

therefore will not be discussed in this 

document. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46075 

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 

New requests to be placed on the lists ................... 2,000 1 2,000 1 ................................ 2,000 

Biennial update ........................................................ 2,000 1 2,000 0.5 (30 minutes) ........ 1,000 

Occasional updates ................................................. 200 1 200 0.5 (30 minutes) ........ 100 

Total .................................................................. ........................ ........................ ........................ .................................... 3,100 

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

FDA bases its estimate on the number 

of manufacturers/processors that have 

submitted new written requests, 

biennial updates, and occasional 

updates over the past 10 years. The 

estimate of the number of burden hours 

it will take a manufacturer/processor to 

gather the information needed to be 

placed on the list or update its 

information is based on FDA’s 

experience with manufacturers/ 

processors submitting similar requests. 

FDA believes that the information to be 

submitted will be readily available to 

manufacturers/processors. This 

collection is also incorporating 

information collected to maintain lists 

of eligible exporters of dairy products 

who wish to export to the EU from OMB 

control number 0910–0320, ‘‘Request for 

Information from U.S. Processors that 

Export to the European Community.’’ 

FDA estimates that 2,000 firms will 

average 60 minutes (1 hour) to submit 

new requests for inclusion on the list, 

2,000 firms will average 30 minutes (0.5 

hour) to update their information every 

2 years, and 200 firms will average 30 

minutes (0.5 hour) to occasionally 

update their information in this system. 

We also believe that submission via the 

electronic registry system will not affect 

the burden estimates. An electronic 

registry will enhance the ability of firms 

to more efficiently request inclusion on 

export lists. FDA calculates, therefore, 

that the total burden for this collection 

is 3,100 hours ((2,000 × 1) plus (2,000 

× 0.5) plus (200 × 0.5)). 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21212 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5767] 

Abbreviated New Drug Applications for 

Certain Highly Purified Synthetic 

Peptide Drug Products That Refer to 

Listed Drugs of Recombinant 

Deoxyribonucleic Acid Origin; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘ANDAs 

for Certain Highly Purified Synthetic 

Peptide Drug Products That Refer to 

Listed Drugs of rDNA Origin.’’ The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) permits any person to 

submit to the FDA an abbreviated new 

drug application (ANDA) to seek 

approval to market a generic version of 

a previously approved drug product. 

This draft guidance is intended to assist 

potential applicants in determining 

when an application for a synthetic 

peptide drug product (specifically 

glucagon, liraglutide, nesiritide, 

teriparatide, and teduglutide) that refers 

to a previously approved peptide drug 

product of recombinant 

deoxyribonucleic acid (rDNA) origin 

should be submitted as an ANDA rather 

than as new drug application (NDA). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 4, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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’’). 

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– 

2017–D–5767 for ‘‘ANDAs for Certain 

Highly Purified Synthetic Peptide Drug 

Products That Refer to Listed Drugs of 

rDNA Origin.’’ 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. 


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