Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments; Correction, 19672 [2012-7756]
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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
VerDate Mar<15>2010
17:42 Mar 30, 2012
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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.
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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.
Notice of public hearing; request
for comments; correction.
ACTION:
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.
SUMMARY:
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.
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.’’
SUPPLEMENTARY INFORMATION:
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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02APN1
]]>Agencies
[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Page 19672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7756]
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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
