Agency Information Collection Activities; Submission for Office of Management and Budget Review; Food Contact Substances Notification, 61452-61453 [05-21155]
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61452
Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
alternative ways. A biowaiver may be
granted if it can be shown that the
generic soluble powder oral dosage form
product or Type A medicated article
contains the same active and inactive
ingredient(s) and is using the same
manufacturing processes as the
approved comparator product or article.
Alternatively, a biowaiver may be
granted without direct comparison to
the pioneer product‘s formulation and
manufacturing process if it can be
shown that the active pharmaceutical
ingredient(s), is the same as the pioneer
product, is soluble , and that there are
no ingredients in the formulation likely
to cause adverse pharmacologic effects.
For the purpose of evaluating soluble
powder oral dosage form products and
Type A medicated articles, solubility
can be demonstrated in two ways: ‘‘USP
definition’’ approach or ‘‘Dosage
Adjusted’’ approach.
In the Federal Register of August 3,
2004 (69 FR 46553), the agency
requested comments on this collection
of information. In response to that
notice, the agency received several
comments on the guidance, two from
individuals who were generally
favorable and one from the Animal
Health Institute (AHI), which was
supportive of some aspects of the
proposed guidance and not supportive
of others. None of the comments
received took issue with any aspect of
the paperwork burden associated with
the draft policy. The Center for
Veterinary Medicine has revised the
substance of the proposed guidance in
several respects in response to AHI
comments.
The respondents for this collection of
information are pharmaceutical
companies manufacturing animal drugs.
FDA estimates the burden for this
collection of information as follows in
tables 1 and 2 of this document. The
source of the data is records of generic
drug applications over the past 10 years.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS1
Annual Frequency per
Responses
No. of Respondents
Same Formulation / Manufacturing Process Approach
Same API / Solubility Approach
Total Burden Hours
1There
Total Annual Responses
Hours per Response
Total Hours
1
1
1
5
5
5
5
5
10
50
55
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES1
Annual Frequency per
Responses
No. of Respondents
Same Formulation / Manufacturing Process Approach.
Same API / Solubility Approach
Total Burden Hours
1There
Total Annual Responses
Total Hours
2
2
2
5
10
10
10
10
20
200
210
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21154 Filed 10–21–05; 8:45 am]
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
BILLING CODE 4160–01–S
DATES:
Fax written comments on the
collection of information by November
23, 2005.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2005N–0209]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review; Food
Contact Substances Notification
AGENCY:
Food and Drug Administration,
HHS.
FOR FURTHER INFORMATION CONTACT:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Aug<31>2005
15:19 Oct 21, 2005
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 comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
ADDRESSES:
Food and Drug Administration
ACTION:
Hourse per Response
Jkt 208001
Peggy Robbins, Office of Management
Programs (HFA 250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\24OCN1.SGM
24OCN1
61453
Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
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.
Description of Respondents:
Manufacturers of food contact
substances.
In the Federal Register of June 7, 2005
(70 FR 33180), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
Form
Annual Frequency per
Response
Total Annual
Responses
Hours per Response
Total Hours
170.1062
(Category A)
5
FDA 3479
1
5
2
10
170.1013,7
(Category B)
5
FDA 3480
1
5
25
125
170.1014,7
(Category C)
5
FDA 3480
2
10
120
1,200
170.1015,7
(Category D)
33
FDA 3480
2
66
150
9,900
170.1016,7
(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.
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.
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).
VerDate Aug<31>2005
15:19 Oct 21, 2005
Jkt 208001
• 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: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21155 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0396]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Dispute
Resolution; Appeals Above the
Division Level
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
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61452-61453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0209]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Food Contact Substances Notification
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
November 23, 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 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: Peggy Robbins, Office of Management
Programs (HFA 250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 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
[[Page 61453]]
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.
Description of Respondents: Manufacturers of food contact
substances.
In the Federal Register of June 7, 2005 (70 FR 33180), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Annual Frequency per Total Annual
Section No. of Respondents Form Response Responses Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
170.106\2 5 FDA 1 5 2 10
\ 3479
(Category
A)
----------------------------------------------------------------------------------------------------------------
170.101\3 5 FDA 1 5 25 125
,7\ 3480
(Category
B)
----------------------------------------------------------------------------------------------------------------
170.101\4 5 FDA 2 10 120 1,200
,7\ 3480
(Category
C)
----------------------------------------------------------------------------------------------------------------
170.101\5 33 FDA 2 66 150 9,900
,7\ 3480
(Category
D)
----------------------------------------------------------------------------------------------------------------
170.101\6 30 FDA 1 30 150 4,500
,7\ 3480
(Category
E)
----------------------------------------------------------------------------------------------------------------
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: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21155 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S
