Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program, 34955-34958 [2012-14227]
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Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—(OMB
Control Number 0910–0582)—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of 21 CFR part 812,
Investigational Device Exemptions,
under 21 CFR 812.2(c)(3), but FDA’s
regulations for the protection of human
subjects (21 CFR parts 50 and 56) apply
to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21
CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and
21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
34955
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level 1 guidance document,
entitled ‘‘Guidance on Informed
Consent for In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens That Are Not Individually
Identifiable,’’ issued under the Good
Guidances Practices regulation, 21 CFR
10.115, FDA outlines the circumstances
in which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
The recommendations of the guidance
impose a minimal burden on industry.
FDA estimates that 700 studies will be
affected annually. Each study will result
in one annual record, estimated to take
4 hours to complete. This results in a
total recordkeeping burden of 2,800
hours (700 × 4 = 2,800).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Federal Food, Drug, and Cosmetic Act section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
520(g) (21 U.S.C. 360j(g)) ...............................
700
1
700
4
2,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 12,
2012.
[FR Doc. 2012–14228 Filed 6–11–12; 8:45 am]
BILLING CODE 4160–01–P
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 0910–0495. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Contact
Substance Notification Program
srobinson on DSK4SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Denver Presley, II, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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collection of information to OMB for
review and clearance.
Food Contact Substance Notification
Program—21 CFR 170.101, 170.106,
and 171.1 (Control Number 0910–
0495)—Extension
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
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34956
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
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) 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
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.,
Electronic Submissions Gateway (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 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
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
srobinson on DSK4SPTVN1PROD with NOTICES
21 CFR Section or other
category
170.106 2 (Category A) .......
170.101 3, 7 (Category B) ....
170.101 4, 7 (Category C) ....
170.101 5, 7 (Category D) ....
170.101 6, 7 (Category E) ....
Pre-notification Consultation
or Master File (concerning a food contact
substance).8
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FDA Form No.
FDA
FDA
FDA
FDA
FDA
FDA
22:42 Jun 11, 2012
3479
3480
3480
3480
3480
3480
Jkt 226001
Number of
responses per
respondent
Number of
respondents
.......
.......
.......
.......
.......
.......
PO 00000
5
5
5
33
30
60
Frm 00024
Fmt 4703
Total annual
responses
1
1
2
2
1
1
Sfmt 4703
Average burden
per response
5
5
10
66
30
60
E:\FR\FM\12JNN1.SGM
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2
25
120
150
150
0.5
Total hours
10
125
1,200
9,900
4,500
30
34957
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
21 CFR Section or other
category
FDA Form No.
Number of
respondents
Total annual
responses
Average burden
per response
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
171.1 Indirect Food Additive
Petitions.
Use of Recycled Plastics in
Food Packaging: Chemistry Considerations.
FDA 3480A .....
50
1
50
0.5
25
N/A ..................
1
1
1
10,995
10,995
N/A ..................
10
1
10
25
250
Total .............................
.........................
............................
............................
............................
............................
27,035
Total hours
1
srobinson on DSK4SPTVN1PROD with NOTICES
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.
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 through
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
hours per response, for a total burden of
10 hours. FDA also has included five
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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 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
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Frm 00025
Fmt 4703
Sfmt 4703
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
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34958
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
burden to be 25 hours per response, for
a total burden of 250 hours.
As noted, FDA estimates that all of
the future Forms FDA 3479, 3480, and
3480A submissions will be made
electronically through 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 to $30.
Dated: June 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14227 Filed 6–11–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0835]
Draft Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors: Considerations When
Transferring Clinical Investigation
Oversight to Another Institutional
Review Board; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Considerations When Transferring
Clinical Investigation Oversight to
Another IRB.’’ The draft guidance
discusses regulatory responsibilities of
institutional review boards (IRBs),
clinical investigators, and sponsors
when oversight of a previously
approved clinical investigation under
FDA’s jurisdiction is transferred from
one IRB to another IRB. The draft
guidance also addresses questions that
have been previously raised concerning
procedures and processes that are
required and/or recommended by FDA
when such oversight is transferred.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either written or electronic comments
on the draft guidance by August 13,
2012.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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Jkt 226001
the Division of Drug Information, Center
for Drug Evaluation and Research
(CDER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 2201, Silver Spring, MD 20993–
0002 (1–888–463–6332 or 301–796–
3400); or the Office of Communication,
Outreach and Development (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448
(1–800–835–4709 or 301–827–1800); or
the Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health (CDRH), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4622, Silver Spring,
MD 20993 (1–800–638–2041 or 301–
796–7100). Send one self-addressed
adhesive label to assist that office in
processing your requests.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Bridget Foltz, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg, 32,
Rm. 5174, Silver Spring, MD 20993–
0002, 301–796–8340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled
‘‘Considerations When Transferring
Clinical Investigation Oversight to
Another IRB.’’ The draft guidance
discusses the regulatory responsibilities
of IRBs, clinical investigators, and
sponsors when oversight of a previously
approved clinical investigation under
FDA’s jurisdiction is transferred from
one IRB to another IRB. In particular,
the draft guidance discusses eight steps
to be considered when transferring
oversight of a previously approved
clinical investigation between two IRBs.
These include: Identifying those studies
for which IRB oversight is being
transferred; ensuring availability and
retention of pertinent records;
establishing an effective date for the
transfer; conducting a review of research
by the receiving IRB, where appropriate;
confirming or establishing the date for
the next continuing review; determining
whether the consent form needs to be
revised; notifying the key parties; and
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updating IRB registration information.
This list is not meant to be exhaustive
as the circumstances involved in the
transfer may vary.
To enhance human subject
protections and reduce regulatory
burden, FDA and the Office for Human
Research Protections (OHRP) have been
actively working to harmonize the
Agencies’ regulatory requirements and
guidance for human subjects research.
This draft guidance document was
developed as a part of these efforts.
OHRP has simultaneously published in
this same issue of the Federal Register
a draft guidance document entitled
‘‘Considerations in Transferring a
Previously Approved Research Project
to a New IRB or Research Institution’’
that is similar to FDA’s draft document.
FDA and OHRP recognize that the two
documents may appear somewhat
different as there are minor variations in
formatting and some necessary
variations due to differences in the
regulated entities under FDA’s and
OHRP’s jurisdiction. The Agencies wish
to stress, however, that our intent was
to provide harmonized guidance to
IRBs, sponsors, institutions,
investigators, and other entities
involved in the study oversight transfer
process. FDA and OHRP will continue
to work closely in the development of
final guidance and appreciate comments
from interested parties.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance includes
information collections provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information referenced in this draft
guidance that are related to IRB
recordkeeping requirements under 21
CFR 56.115, which include the
requirements for records related to
informed consent, have been approved
under OMB control number 0910–0130;
the collection of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; and
the collections of information in 21 CFR
part 812 have been approved under
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]]>Agencies
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34955-34958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14227]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0294]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Contact
Substance Notification Program
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 July
12, 2012.
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 0910-0495.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Food Contact Substance Notification Program--21 CFR 170.101, 170.106,
and 171.1 (Control Number 0910-0495)--Extension
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
[[Page 34956]]
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)
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 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., Electronic Submissions
Gateway (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 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section or other category FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 FDA 3480................. 60 1 60 0.5 30
Master File (concerning a food
contact substance).\8\
[[Page 34957]]
Amendment to an existing FDA 3480A................ 50 1 50 0.5 25
notification (170.101), amendment
to a Pre-notification
Consultation, or amendment to a
Master File (concerning a food
contact substance).\9\
171.1 Indirect Food Additive N/A...................... 1 1 1 10,995 10,995
Petitions.
Use of Recycled Plastics in Food N/A...................... 10 1 10 25 250
Packaging: Chemistry
Considerations.
������������������������������������
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.
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 through 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 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 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 non-substantive request of additional information to an incomplete
FCN submission, for an amendment to a Pre-notification 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 Sec.
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
[[Page 34958]]
burden to be 25 hours per response, for a total burden of 250 hours.
As noted, FDA estimates that all of the future Forms FDA 3479,
3480, and 3480A submissions will be made electronically through 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 to $30.
Dated: June 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14227 Filed 6-11-12; 8:45 am]
BILLING CODE 4160-01-P
