Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46493 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction.500 1 20/60 

57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.500 1 20/60 

57.400 Outpatient Procedure Component—Annual Facility 

Survey.

5,000 1 10/60 

57.401 Outpatient Procedure Component—Monthly Reporting Plan.5,000 12 20/60 

57.402 Outpatient Procedure Component Same Day Outcome Measures.1,200 25 40/60 

57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures.1,200 12 40/60 

57.404 Outpatient Procedure Component—SSI Denominator.5,000 540 10/60 

57.405 Outpatient Procedure Component—Surgical Site 

(SSI) Event.

5,000 36 35/60 

57.500 Outpatient Dialysis Center Practices Survey ............. 7,000 1 127/60 

57.501 Dialysis Monthly Reporting Plan ................................ 7,000 12 5/60 

57.502 Dialysis Event ............................................................. 7,000 60 25/60 

57.503 Denominator for Outpatient Dialysis .......................... 7,000 12 10/60 

57.504 Prevention Process Measures Monthly Monitoring 

for Dialysis.

2,000 12 85/60 

57.505 Dialysis Patient Influenza Vaccination ....................... 325 75 10/60 

57.506 Dialysis Patient Influenza Vaccination Denominator 325 5 10/60 

57.507 Home Dialysis Center Practices Survey .................... 350 1 30/60 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–19902 Filed 9–12–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0294] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Contact 

Substance Notification Program 

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 information 

collection associated with the Food 

Contact Substance Notification Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 13, 2018. 

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 November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

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– 

2012–N–0294 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 


daltland on DSKBBV9HB2PROD with NOTICES
46494 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

Contact Substance Notification 

Program.’’ 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. 

• 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 

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.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: 

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: Under the 

PRA (44 U.S.C. 3501–3520), 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. 

Food Contact Substance Notification 

Program—21 CFR 170.101, 170.106, 

and 171.1 

OMB Control Number 0910–0495— 

Extension 

This information collection supports 

FDA regulations regarding Food Contact 

Substance Notification, as well as 

associated guidance and accompanying 

forms. Section 409(h) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 348(h)) establishes a 

premarket notification process for food 

contact substances. Section 409(h)(6) of 

the FD&C Act defines a ‘‘food contact 

substance’’ as ‘‘any substance intended 

for use as a component of materials used 

in manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the FD&C Act requires that the 

notification process be used for 

authorizing the marketing of food 

contact substances except when: (1) We 

determine that the submission and 

premarket review of a food additive 

petition (FAP) under section 409(b) of 

the FD&C Act is necessary to provide 

adequate assurance of safety or (2) we 

and the manufacturer or supplier agree 

that an FAP should be submitted. 

Section 409(h)(1) of the FD&C Act 

requires that a notification include: (1) 

Information on the identity and the 

intended use of the food contact 

substance and (2) the basis for the 

manufacturer’s or supplier’s 

determination that the food contact 

substance is safe under the intended 

conditions of use. 

Sections 170.101 and 170.106 of 

FDA’s regulations (21 CFR 170.101 and 

170.106) specify the information that a 

notification must contain and require 

that: (1) A food contact substance 

notification (FCN) includes Form FDA 

3480 and (2) a notification for a food 

contact substance formulation includes 

Form FDA 3479. These forms serve to 

summarize pertinent information in the 

notification. The forms facilitate both 

preparation and review of notifications 

because the forms will serve to organize 

information necessary to support the 

safety of the use of the food contact 

substance. The burden of filling out the 

appropriate form has been included in 

the burden estimate for the notification. 

Currently, interested persons transmit 

an FCN submission to the Office of Food 

Additive Safety in the Center for Food 

Safety and Applied Nutrition using 

Form FDA 3480 whether it is submitted 

in electronic or paper format. We 

estimate that the amount of time for 

respondents to complete Form FDA 

3480 will continue to be the same. 

In addition to its required use with 

FCNs, Form FDA 3480 is recommended 

to be used to organize information 

within a Pre-notification Consultation or 

Master File submitted in support of an 

FCN according to the items listed on the 

form. Master Files can be used as 

repositories for information that can be 

referenced in multiple submissions to 

FDA, thus minimizing paperwork 

burden for food contact substance 

authorizations. We estimate that the 

amount of time for respondents to 

complete the Form FDA 3480 for these 

types of submissions is 0.5 hours. 

FDA recommends using Form FDA 

3480A for each submission of additional 

information (i.e., amendment) to an FCN 

submission currently under Agency 

review. Form FDA 3480A helps the 

respondent organize the submission to 

focus on the information needed for 

FDA’s safety review. 

FDA’s guidance documents entitled: 

(1) ‘‘Preparation of Food Contact 

Notifications: Administrative,’’ (2) 

‘‘Preparation of Food Contact 

Notifications and Food Additive 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46495 

Petitions for Food Contact Substances: 

Chemistry Recommendations,’’ and (3) 

‘‘Preparation of Food Contact 

Notifications for Food Contact 

Substances: Toxicology 

Recommendations’’ provide assistance 

to industry regarding the preparation of 

an FCN and a petition for a food contact 

substances (FCSs). FDA has also 

developed a draft guidance entitled, 

‘‘Preparation of Food Contact 

Notifications for Food Contact 

Substances in Contact with Infant 

Formula and/or Human Milk.’’ Once 

finalized, the guidance will provide our 

current thinking on how to prepare an 

FCN for FDA review and evaluation of 

the safety of FCSs used in contact with 

infant formula and/or human milk. 

These guidances are available at https:// 

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/ 

IngredientsAdditivesGRASPackaging/ 

default.htm. 

Section 171.1 of FDA’s regulations (21 

CFR 171.1) specifies the information 

that a petitioner must submit in order 

to: (1) Establish that the proposed use of 

an indirect food additive is safe and (2) 

secure the publication of an indirect 

food additive regulation in parts 175 

through 178 (21 CFR parts 175 through 

178). Parts 175 through 178 describe the 

conditions under which the additive 

may be safely used. 

In addition, FDA’s guidance entitled 

‘‘Use of Recycled Plastics in Food 

Packaging: Chemistry Considerations,’’ 

provides assistance to manufacturers of 

food packaging in evaluating processes 

for producing packaging from postconsumer recycled plastic. The 

recommendations in the guidance 

address the process by which 

manufacturers certify to us that their 

plastic products are safe for food 

contact. 

Description of Respondents: The 

respondents to this information 

collection are manufacturers of food 

contact substances sold in the United 

States. Respondents are from the private 

sector (for-profit businesses). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity FDA form 

No. 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

170.106 2 (Category A) ............................................... FDA 3479 10 2 20 2 40 

170.101 3,7 (Category B) ............................................ FDA 3480 6 1 6 25 150 

170.101 4,7 (Category C) ............................................ FDA 3480 6 2 12 120 1,440 

170.101 5,7 (Category D) ............................................ FDA 3480 42 2 84 150 12,600 

170.101 6,7 (Category E) ............................................ FDA 3480 38 1 38 150 5,700 

Pre-notification Consultation or Master File (concerning a food contact substance).8FDA 3480 190 1 190 *0.5 95 

Amendment to an existing notification (170.101), 

amendment to a Pre-notification Consultation, or 

amendment to a Master File (concerning a food 

contact substance).9

FDA 3480A 100 1 100 *0.5 50 

171.1 Indirect Food Additive Petitions ....................... N/A 1 1 1 10,995 10,995 

Use of Recycled Plastics in Food Packaging: Chemistry Considerations.N/A 10 1 10 25 250 

Preparation of Food Contact Notifications for Food 

Contact Substances in Contact with Infant Formula and/or Human Milk.

2 1 2 5 10 

Total .................................................................... ........................ .................... .................... .................... 31,330 

* 30 minutes. 

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

2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479 

(‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 

4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 

5 Notifications for uses that are the subject of moderately complex food additive petitions. 

6 Notifications for uses that are the subject of very complex food additive petitions. 

7These notifications require the submission of Form FDA 3480. 

8These notifications recommend the submission of Form FDA 3480. 

9These notifications recommend the submission of Form FDA 3480A. 

The estimates are based on our 

current experience with the Food 

Contact Substance Notification Program 

and informal communication with 

industry. Our estimated burden for the 

information collection reflects an 

overall increase of 10 hours and a 

corresponding increase of 2 responses 

from the currently approved burden. We 

attribute this adjustment to reviewing 

and submitting FCNs consistent to the 

draft guidance entitled, ‘‘Preparation of 

Food Contact Notifications for Food 

Contact Substances in Contact with 

Infant Formula and/or Human Milk.’’ 

Beginning in row 1, we estimate 10 

respondents will submit 2 notifications 

annually for food contact substance 

formulations (Form FDA 3479), for a 

total of 20 responses. We calculate a 

reporting burden of 2 hours per 

response, for a total of 40 hours. In row 

2 we estimate six respondents. We 

believe the hourly burden for preparing 

these notifications will primarily consist 

of the manufacturer or supplier 

completing Form FDA 3480, verifying 

that a previous notification is effective 

and preparing necessary documentation. 

We estimate one submission for each 

respondent, for a total of six responses. 

We calculate a reporting burden of 25 

hours per response, for a total of 150 

hours. 

In rows 3, 4, and 5, we identify three 

tiers of FCNs that reflect different levels 

of burden applicable to the respective 

information collection items (denoted as 

Categories C, D, and E). We estimate 6 

respondents will submit 2 Category C 

submissions annually, for a total of 12 


daltland on DSKBBV9HB2PROD with NOTICES
46496 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

responses. We calculate a reporting 

burden of 120 hours per response, for a 

total burden of 1,440 hours. We estimate 

42 respondents will submit 2 Category 

D submissions annually, for a total of 84 

responses. We calculate a reporting 

burden of 150 hours per response, for a 

total burden of 12,600 hours. We 

estimate 38 respondents will submit 1 

Category E submission annually, for a 

total of 38 responses. We calculate a 

reporting burden of 150 hours per 

response, for a total burden of 5,700 

hours. 

In row 6, we estimate 190 respondents 

will submit information to a prenotification consultation or a master file 

in support of FCN submission using 

Form FDA 3480. We calculate a 

reporting burden of 0.5 hours per 

response, for a total burden of 95 hours. 

In row 7 we estimate 100 respondents 

will submit an amendment (Form FDA 

3480A) to a substantive or nonsubstantive request of additional 

information to an incomplete FCN 

submission, an amendment to a prenotification consultation, or an 

amendment to a master file in support 

of an FCN. We calculate a reporting 

burden of 0.5 hours per response, for a 

total burden of 50 hours. 

In row 8, we estimate one respondent 

will submit one indirect food additive 

petition under § 171.1, for a total of one 

response. We calculate a reporting 

burden of 10,995 hours per response, for 

a total burden of 10,995 hours. 

In row 9, we estimate 10 respondents 

will utilize the recommendations in the 

guidance document entitled, ‘‘Use of 

Recycled Plastics in Food Packaging: 

Chemistry Considerations,’’ to develop 

the additional information for one such 

submission annually, for a total of 10 

responses. We calculate a reporting 

burden of 25 hours per response, for a 

total burden of 250 hours. 

Finally, in row 10, we estimate 2 

respondents will utilize the 

recommendations in the draft guidance, 

once finalized, entitled, ‘‘Preparation of 

Food Contact Notifications for Food 

Contact Substances in Contact with 

Infant Formula and/or Human Milk,’’ to 

develop the additional information for 

one such submission annually, for a 

total of 2 responses. We calculate a 

reporting burden of 5 hours per 

response, for a total burden of 10 hours. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19898 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1857] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals 

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 October 15, 

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 0910–0789. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Current Good Manufacturing Practice 

and Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals—21 CFR Part 507 

OMB Control Number 0910–0789— 

Extension 

The information collection supports 

FDA regulations. As amended by the 

FDA Food Safety Modernization Act 

(FSMA) (Pub. L. 111–353), the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) enables the Agency to better protect 

the public health by helping to ensure 

the safety and security of the food 

supply. It enables FDA to focus more on 

preventing food safety problems rather 

than relying primarily on reacting to 

problems after they occur. FSMA 

recognizes the important role industry 

plays in ensuring the safety of the food 

supply, including the adoption of 

modern systems of preventive controls 

in food production. Specifically, section 

418 (21 U.S.C. 350g) of the FD&C Act 

sets forth requirements for hazard 

analysis and risk-based preventive 

controls for facilities that produce food 

for animals. To implement these 

provisions, regulations were codified 

under 21 CFR part 507—Current Good 

Manufacturing Practice, Hazard 

Analysis, And Risk-Based Preventive 

Controls For Food For Animals. The 

regulations establish requirements for a 

written food safety plan; hazard analysis 

preventive controls; monitoring; 

corrective actions and corrections; 

verification; supply-chain program; 

recall plan; and associated records and 

became effective November 16, 2015. 

Currently, we continue to evaluate 

burden associated with the information 

collection requirements however, for 

purposes of extending the information 

collection we retain the currently 

approved figures as shown in the 

following tables. 

In the Federal Register of May 24, 

2018 (83 FR 24124), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received three 

comments, however none pertained to 

the information collection or underlying 

regulations. 

We estimate our burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per response Total hours 

507.7 exemption: submit attestation of preventive controls or compliance with 

State and local laws (non-federal).

1,120 0.5 560 0.5 (30 minutes) ............. 280 


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