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] 

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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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