19670 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 

Panel; Member conflict: Chemosensory, 

Pain and Hearing. 

Date: April 18–19, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: John Bishop, Ph.D, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

5182, MSC 7844, Bethesda, MD 20892, 

(301) 408–9664, bishopj@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 27, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7821 Filed 3–30–12; 8:45 am] 

BILLING CODE 4140–01–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) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 collection of information associated 

with the Food Contact Substance 

Notification Program, including 

revisions to Form FDA 3480, new Form 

FDA 3480A, and electronic submission 

via the Electronic Submission Gateway 

(ESG). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 29, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT:

With regard to the information 

collection: Denver Presley, Jr., Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3793. 

With regard to the Food Contact 

Substance Notification Program: 

Kenneth A. McAdams, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy (HFS–275), College Park, MD 

20740, 240–402–1224, Fax: 301–436– 

2965, email: 

Kenneth.mcadams@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)—Revision 

Section 409(h) of the Federal Food, 

Drug, and Cosmetic Act (the 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) 

FDA determines 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) FDA 

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 (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) 

include a completed and signed Form 

FDA 3480 and (2) a notification for a 

food contact substance formulation 

include a completed and signed 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 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. FDA 

recently made minor revisions to Form 

FDA 3480 to better enable its use for 

electronic submission and to prompt 

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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 19671 

FCN submitters to include certain 

information in a standard format. FDA 

estimates that the revisions to Form 

FDA 3480 will not change the amount 

of time necessary to complete the form. 

In addition to its required use with 

FCNs, revised 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 the Agency, 

thus minimizing paperwork burden for 

food contact substance authorizations. 

FDA estimates that the amount of time 

for respondents to complete the revised 

Form FDA 3480 for these types of 

submissions will be 0.5 hours. 

FDA has recently developed a new 

form, which the Agency recommends be 

used with each submission of additional 

information (i.e. amendment) to an FCN 

submission currently under Agency 

review, as well as be used to submit an 

amendment to a Pre-notification 

Consultation, or for an amendment to 

Master File in support of an FCN, 

whether submitted in electronic format 

or paper format. New Form FDA 3480A 

is entitled ‘‘Amendment to an Existing 

Food Contact Substance Notification, a 

Pre-Notification Consultation, or a Food 

Master File.’’ The form, and elements 

that would be prepared as attachments 

to the form, can be submitted in 

electronic format. Form FDA 3480A 

helps the respondent organize their 

submission to focus on the information 

needed for FDA’s safety review. FDA 

estimates that the amount of time for 

respondents to complete the new Form 

FDA 3480A will be 0.5 hours because 

the new form, used solely for 

transmitting an amendment, is much 

shorter than Form FDA 3480. 

Amendments include the following 

information on new Form FDA 3480A 

and in attachments to the form: 

• Date of submission; 

• Whether the notifier has 

determined that all files provided in an 

electronic transmission are free of 

computer viruses; 

• Whether the submission is an 

amendment to an FCN submission, a 

pre-notification consultation, or a 

master file; 

• The format of the submission (i.e., 

ESG, transmission on electronic 

physical media such as CD–ROM or 

DVD, or paper); 

• The name of and contact 

information for the submitter, including 

the identity of the contact person and 

the company name (if applicable); 

• The name of and contact 

information for any agent or attorney 

who is authorized to act on behalf of the 

notifier; and 

• A brief description of the 

information provided and the 

purpose(s) of the amendment. 

Section 171.1 (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 

document entitled ‘‘Use of Recycled 

Plastics in Food Packaging: Chemistry 

Considerations’’ provides assistance to 

manufacturers of food packaging in 

evaluating processes for producing 

packaging from post-consumer recycled 

plastic. The recommendations in the 

guidance address the process by which 

manufacturers certify to FDA that their 

plastic products are safe for food 

contact. 

Description of Respondents: The 

respondents to this information 

collection are manufacturers of food 

contact substances. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section or other category 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 ............ 5 1 5 2 10 

170.101 3 7 (Category B) ................... FDA 3480 ............ 5 1 5 25 125 

170.101 4 7 (Category C) ................... FDA 3480 ............ 5 2 10 120 1,200 

170.101 5 7 (Category D) ................... FDA 3480 ............ 33 2 66 150 9,900 

170.101 6 7 (Category E) ................... FDA 3480 ............ 30 1 30 150 4,500 

Pre-notification Consultation or Master File (concerning a food contact 

substance) 8

FDA 3480 ............ 60 1 60 0 .5 30 

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 ......... 50 1 50 0 .5 25 

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 

Total ........................................... ............................. ........................ ........................ ........................ .......................... 27,035 

1 There 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. 7 These notifications require the submission of Form FDA 3480. 8 These notifications recommend the submission of Form FDA 3480. 9 These notifications recommend the submission of Form FDA 3480A. 

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19672 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 

The forms in table 1 of this document, 

and elements that would be prepared as 

attachments to the forms, may be 

submitted in electronic format via the 

ESG; email, if appropriate; or may be 

submitted in paper format, or as 

electronic files on physical media with 

paper signature page. FDA expects that 

most if not all businesses filing these 

submissions in the next 3 years will 

choose to take advantage of the option 

of electronic submission. Thus, the 

burden estimates in table 1 of this 

document are based on the expectation 

of 100 percent participation in the 

electronic submission process. The 

opportunity to provide the information 

in electronic format could reduce the 

Agency’s previous estimates for the time 

to prepare each submission. However, 

as a conservative approach for the 

purpose of this analysis, FDA is 

assuming that the availability of the 

revised or new forms and the 

opportunity to submit the information 

in electronic format will have no effect 

on the average time to prepare a 

submission. 

These estimates are based on FDA’s 

experience with the food contact 

substance notification program. Based 

on input from industry sources, FDA 

estimates that approximately five 

respondents will submit one 

notification annually for food contact 

substance formulations (Form FDA 

3479), for a total of five responses. FDA 

estimates the reporting burden to be 2.0 

hours per response, for a total burden of 

10 hours. FDA also has included five 

expected duplicate submissions in the 

second row of table 1 of this document. 

FDA expects that the burden for 

preparing these notifications primarily 

will consist of the manufacturer or 

supplier filling out Form FDA 3480, 

verifying that a previous notification is 

effective, and preparing necessary 

documentation. Thus, FDA estimates 

that five respondents will submit one 

such submission annually, for a total of 

five responses. FDA estimates the 

reporting burden to be 25.0 hours per 

response, for a total burden of 125 

hours. 

Based on the submissions received, 

FDA identified three other tiers of FCNs 

that represent escalating levels of 

burden required to collect information 

(denoted as categories C, D, and E in the 

third, fourth, and fifth rows of table 1 of 

this document). FDA estimated the 

median number of hours necessary for 

collecting information for each type of 

notification within each of the three 

tiers based on input from industry 

sources. FDA estimates that 5 

respondents will submit two category C 

submissions annually, for a total of 10 

responses. FDA estimates the reporting 

burden to be 120 hours per response, for 

a total burden of 1,200 hours. FDA 

estimates that 33 respondents will 

submit two Category D submissions 

annually, for a total of 66 responses. 

FDA estimates the reporting burden to 

be 150 hours per response, for a total 

burden of 9,900 hours. FDA estimates 

that 30 respondents will submit one 

Category E submission annually, for a 

total of 30 responses. FDA estimates the 

reporting burden to be 150 hours per 

response, for a total burden of 4,500 

hours. 

Based on the submissions received, 

FDA estimates that 60 respondents will 

submit information to a pre-notification 

consultation or a master file in support 

of FCN submission using Form FDA 

3480. FDA estimates the reporting 

burden to be 0.5 hours per response, for 

a total burden of 30 hours. 

Based on the submissions received, 

FDA estimates that 50 respondents will 

submit an amendment (Form FDA 

3480A) to a substantive or nonsubstantive request of additional 

information to an incomplete FCN 

submission, for an amendment to a prenotification consultation, or for an 

amendment to a master file in support 

of an FCN. FDA estimates the reporting 

burden to be 0.5 hours per response, for 

a total burden of 25 hours. 

Based on the submissions received, 

FDA estimates that one respondent will 

submit one indirect food additive 

petition under § 171.1, for a total of one 

response. FDA estimates the reporting 

burden to be 10,995 hours per response, 

for a total burden of 10,995 hours. 

FDA estimates that 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. FDA estimates the reporting 

burden to be 25 hours per response, for 

a total burden of 250 hours. 

As noted, FDA estimates that all of 

the future Form FDA 3479, 3480, and 

3480A submissions will be made 

electronically via the ESG. While FDA 

does not charge for the use of the ESG, 

FDA requires respondents to obtain a 

public key infrastructure certificate in 

order to set up the account. This can be 

obtained in-house or outsourced by 

purchasing a public key certificate that 

is valid for 1 year to 3 years. The 

certificate typically costs from $20-$30. 

Dated: March 27, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7764 Filed 3–30–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0618] 

Draft Guidances Relating to the 

Development of Biosimilar Products; 

Public Hearing; Request for 

Comments; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of March 2, 2012 (77 FR 

12853). The document announced a 

public hearing entitled ‘‘Draft 

Guidances Related to the Development 

of Biosimilar Products; Public Hearing; 

Request for Comments’’ to obtain input 

on recently issued draft guidances 

relating to the development of 

biosimilar products. The document 

published with an incorrect date for 

submission of electronic and written 

comments. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Sandra J. Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993–0002, 301– 

796–1042, Fax: 301–847–3529, email: 

biosimilarspublicmtg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2012–5070, appearing on page 12853, in 

the Federal Register of Friday, March 2, 

2012, the following correction is made: 

On page 12853, in the second column, 

in the DATES section, the last sentence is 

corrected to read: ‘‘Electronic or written 

comments will be accepted after the 

public hearing until May 25, 2012.’’ 

Dated: March 26, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7756 Filed 3–30–12; 8:45 am] 

BILLING CODE 4160–01–P 

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