Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System, 33180-33181 [05-11265]
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33180
Federal Register / Vol. 70, No. 108 / Tuesday, June 7, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Annual Frequency per Response
100
1
1 There
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11264 Filed 6–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0209]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Contact
Substances Notification System
AGENCY:
Hours per Response
100
15
Total Hours
1,500
are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible for the AP program. Also 10 to
15 percent of the firms are not eligible
due to the results of their previous
inspection. FDA estimates that there are
4,000 domestic manufacturers and 4,000
foreign manufacturers that are eligible
for inclusion in the AP program. Based
on informal communications with
industry, FDA estimates that
approximately 100 of these
manufacturers may apply to use an AP
in any given year.
Food and Drug Administration,
HHS.
ACTION:
Total Annual Responses
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 Substances
Notification System.
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Submit written or electronic
comments on the collection of
information by August 8, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1223.
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
DATES:
PO 00000
Frm 00126
Fmt 4703
Sfmt 4703
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Contact Substances Notification
System—21 CFR 170.101 and 170.106—
(OMB Control Number 0910–0495)—
Extension
Section 409(h) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(h)) establishes a premarket
notification process for food contact
substances. Section 409(h)(6) of the 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 act requires that the notification
process be used for authorizing the
marketing of food contact substances
except where FDA determines that the
submission and premarket review of a
food additive petition (FAP) under
section 409(b) of the act is necessary to
provide adequate assurance of safety or
where FDA and the manufacturer or
supplier agree that an FAP should be
submitted. Section 409(h)(1) of the act
requires that a notification include
information on the identity and the
intended use of the food contact
substance and 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) require that a food contact
notification (FCN) include FDA Form
3480 entitled ‘‘Notification for New Use
of a Food Contact Substance’’ and that
a notification for a food contact
substance formulation include FDA
Form 3479 entitled ‘‘Notification for a
Food Contact Substance Formulation.’’
These forms will serve to summarize
pertinent information in the
notification. FDA believes that these
forms will 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.
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33181
Federal Register / Vol. 70, No. 108 / Tuesday, June 7, 2005 / Notices
Description of Respondents:
Manufacturers of food contact
substances.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
170.1062 (Category A)
Annual Frequency
per Response
Form
Total Annual
Responses
Hours per
Response
Total Hours
5
FDA 3479
1
5
2
10
170.101
3,7
(Category B)
5
FDA 3480
1
5
25
125
170.101
4,7
(Category C)
5
FDA 3480
2
10
120
1,200
170.101
5,7
(Category D)
33
FDA 3480
2
66
150
9,900
170.101
6,7
(Category E)
30
FDA 3480
1
30
150
4,500
Total
15,735
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
for food contact substance formulations and food contact articles. These notifications require the submission of FDA Form 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.
5Notifications 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 FDA Form 3480.
2 Notifications
These estimates are based on FDA’s
experience with the food contact
substances notification system.
• Based on input from industry
sources, FDA estimates that the agency
will receive approximately five
notifications annually for food contact
substance formulations.
• 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 FDA Form 3480,
verifying that a previous notification is
effective, and preparing necessary
documentation.
• Based on the submissions received,
FDA identified three other tiers of FCNs
that represent escalating levels of
burden required to collect information
(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.
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11265 Filed 6–6–05; 8:45 am]
BILLING CODE 4160–01–S
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20:54 Jun 06, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0003]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
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 7,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
PO 00000
Frm 00127
Fmt 4703
Sfmt 4703
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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. This notice
solicits comments on regulations
requiring the distribution of patient
labeling, called Medication Guides, for
certain products that pose a serious and
significant public health concern
requiring distribution of FDA-approved
patient medication information.
Prescription Drug Product Labeling;
Medication Guide Requirements—
(OMB Control Number 0910–0393—
Extension
FDA regulations require the
distribution of patient labeling, called
Medication Guides, for certain
prescription human drug and biological
products used primarily on an
outpatient basis that pose a serious and
significant public health concern
requiring distribution of FDA-approved
patient medication information. These
Medication Guides inform patients
about the most important information
they should know about these products
in order to use them safely and
effectively. Included is information such
as the drug’s approved uses,
contraindications, adverse drug
reactions, and cautions for specific
populations, with a focus on why the
particular product requires a Medication
Guide. These regulations are intended to
improve the public health by providing
information necessary for patients to use
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]]>Agencies
[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33180-33181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11265]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0209]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Contact Substances Notification System
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 Substances Notification System.
DATES: Submit written or electronic comments on the collection of
information by August 8, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,301-827-1223.
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 Substances Notification System--21 CFR 170.101 and
170.106--(OMB Control Number 0910-0495)--Extension
Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(h)) establishes a premarket notification process
for food contact substances. Section 409(h)(6) of the 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 act requires
that the notification process be used for authorizing the marketing of
food contact substances except where FDA determines that the submission
and premarket review of a food additive petition (FAP) under section
409(b) of the act is necessary to provide adequate assurance of safety
or where FDA and the manufacturer or supplier agree that an FAP should
be submitted. Section 409(h)(1) of the act requires that a notification
include information on the identity and the intended use of the food
contact substance and 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) require that a food contact notification (FCN) include FDA
Form 3480 entitled ``Notification for New Use of a Food Contact
Substance'' and that a notification for a food contact substance
formulation include FDA Form 3479 entitled ``Notification for a Food
Contact Substance Formulation.'' These forms will serve to summarize
pertinent information in the notification. FDA believes that these
forms will 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.
[[Page 33181]]
Description of Respondents: Manufacturers of food contact
substances.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents Form per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106\2\ (Category A) 5 FDA 3479 1 5 2 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \3,7\ (Category B) 5 FDA 3480 1 5 25 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \4,7\ (Category C) 5 FDA 3480 2 10 120 1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \5,7\ (Category D) 33 FDA 3480 2 66 150 9,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \6,7\ (Category E) 30 FDA 3480 1 30 150 4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 15,735
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 FDA Form 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 FDA Form 3480.
These estimates are based on FDA's experience with the food contact
substances notification system.
Based on input from industry sources, FDA estimates that
the agency will receive approximately five notifications annually for
food contact substance formulations.
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 FDA Form 3480, verifying that a
previous notification is effective, and preparing necessary
documentation.
Based on the submissions received, FDA identified three
other tiers of FCNs that represent escalating levels of burden required
to collect information (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.
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11265 Filed 6-6-05; 8:45 am]
BILLING CODE 4160-01-S
