Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions, 66541-66543 [E6-19201]
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VerDate Aug<31>2005
15:00 Nov 14, 2006
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Technology Circle, Columbia, SC 29203–
0001.
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Service, P.O. Box 8190, Madison, WI
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Insurance Co., P.O. Box 16788, 1
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DMERC, 17 Technology Circle, Columbia,
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Enterprises, 901 South Central Expressway,
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Medicare Coordinator, Nordian, 636 Grand
Avenue, Des Moines, IA 50309–2551.
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0001.
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PO 00000
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66541
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[FR Doc. E6–19212 Filed 11–14–06; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0328]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Additive
Petitions
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.
Fax written comments on the
collection of information by December
15, 2006.
DATES:
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:
202–395–6974.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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:
E:\FR\FM\15NON1.SGM
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66542
Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Notices
Food Additive Petitions—21 CFR Part
571 (OMB Control Number 0910–
0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(a)), provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the act (21 U.S.C.
348(b)) specifies the information that
must be submitted by a petition in order
to establish the safety of a food additive
and to secure the issuance of a
regulation permitting its use.
To implement the provision of section
409 of the act (21 U.S.C. 348),
procedural regulations have been issued
under part 571 (21 CFR part 571). These
procedural regulations are designed to
specify more thoroughly the information
that must be submitted to meet the
requirement set down in broader terms
by the law. The regulations add no
substantive requirements to those
indicated in the law, but attempt to
explain the requirements and provide a
standard format for submission to speed
the processing of the petition. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in 21 CFR parts 573 and 582.
The labeling regulations are considered
by FDA to be cross-referenced to
§ 571.1, which is the subject of this
same OMB clearance for food additive
petitions.
On September 29, 2004, OMB
approved a new information collection
on food additive petitions submitted by
the Center for Veterinary Medicine
(CVM). The terms of clearance for this
information collection stated that, given
the interrelatedness of this collection to
the information collected under OMB
control number 0910–0016 by the
Center for Food Safety and Applied
Nutrition (CFSAN), FDA should
consider merging the two collections. In
consultation with CFSAN, CVM has
decided not to merge these two
collections, because what was once a
food additive petitions approval (OMB
control number 0910–0016), is now also
the approval for affirmation of generally
recognized as safe (GRAS) status
(formerly OMB control number 0910–
0132), labeling requirements for color
additives (other than hair dyes) and
petitions (formerly OMB control number
0910–0185), electronic submission of
food and color additive petitions
(formerly OMB control number 0910–
0480), and substances approved for use
in the preparation of meat and poultry
products (formerly OMB control number
0910–0461). Thus, adding one CVM
process to a collection now containing
four dissimilar CFSAN processes is not
justifiable any more. Finally, the CVM
food additive petition process stems
from a different section of the CFR and
the two processes are handled
separately. CVM’s food additive petition
process relates to part 571; CFSAN’s
process relates to 21 CFR part 171.
There is no efficiency in discussing
these separate processes in a single
collection of information.
Respondents are expected to be the
veterinary feed industry.
FDA estimates the burden of this
collection of information as follows:
The estimated annual burden for this
information collection is 18,000 hours.
Food additive petitions submitted to
CVM are estimated to fall into one of
two categories of complexity that also
can be used to represent estimates of the
information collection burden for food
additive petitions. These include only
expected petitions for food additives not
eligible for exemption under new
section 409(h) of the act (21 U.S.C.
348(h)).
Under § 571.1(c) moderate category,
for a food additive petition without
complex chemistry, manufacturing,
efficacy, or safety issues, the estimated
time requirement per petition is
approximately 3,000 hours. An average
of one petition of this type is received
on an annual basis, resulting in a
burden of 3,000 hours.
Under § 571.1(c) complex category,
for a food additive petition with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
estimated time requirement per petition
is approximately 10,000 hours. An
average of one petition of this type is
received on an annual basis, resulting in
a burden of 10,000 hours.
Under § 571.6, for a food additive
petition amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of four petitions of this type are received
on an annual basis, resulting in a
burden of 5,200 hours.
In the Federal Register of September
1, 2006 (71 FR 52124), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
571.1(c) moderate category
1
1
1
3,000
3,000
571.1(c) complex category
1
1
1
10,000
10,000
571.6
2
2
4
1,300
5,200
Total
rmajette on PROD1PC67 with NOTICES1
1There
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
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66543
Federal Register / Vol. 71, No. 220 / Wednesday, November 15, 2006 / Notices
Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–19201 Filed 11–14–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0452]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Agreement for
Shipment of Devices for Sterilization
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
information collection requirements
relating to shipment of nonsterile
devices that are to be sterilized
elsewhere or are shipped to other
establishments for further processing,
labeling, or repacking.
DATES: Submit written or electronic
comments on the collection of
information by January 16, 2007.
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:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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.
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150(e) (OMB
Control Number 0910–0131)—Extension
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations in § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms. Under § 801.150(e),
manufacturers and sterilizers may sign
an agreement containing the following:
(1) Instructions for maintaining
accountability of the number of units in
each shipment; (2) acknowledgment that
the devices that are nonsterile are being
shipped for further processing; and (3)
specifications for sterilization
processing.
This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices.
The respondents to this collection of
information are device manufacturers
and contact sterilizers.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Annual Frequency
per Response
90
21 CFR Section
20
801.150(e)
1There
Total Annual Responses
Hours per Response
1,800
Total Hours
4
7,200
are no capital costs or operating and maintenance costs associated with this collection of information.
rmajette on PROD1PC67 with NOTICES1
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency of
Recordkeeping
90
21 CFR Section
20
801.150(a)(2)
1There
Total Annual
Records
Hours per Record
1,800
0.5
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
15:00 Nov 14, 2006
Jkt 211001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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15NON1
Total Hours
900
]]>Agencies
[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66541-66543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19201]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0328]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additive
Petitions
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
December 15, 2006.
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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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.
[[Page 66542]]
Food Additive Petitions--21 CFR Part 571 (OMB Control Number 0910-
0546)--Extension
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(a)), provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the act (21 U.S.C. 348(b)) specifies the information that
must be submitted by a petition in order to establish the safety of a
food additive and to secure the issuance of a regulation permitting its
use.
To implement the provision of section 409 of the act (21 U.S.C.
348), procedural regulations have been issued under part 571 (21 CFR
part 571). These procedural regulations are designed to specify more
thoroughly the information that must be submitted to meet the
requirement set down in broader terms by the law. The regulations add
no substantive requirements to those indicated in the law, but attempt
to explain the requirements and provide a standard format for
submission to speed the processing of the petition. Labeling
requirements for food additives intended for animal consumption are
also set forth in various regulations contained in 21 CFR parts 573 and
582. The labeling regulations are considered by FDA to be cross-
referenced to Sec. 571.1, which is the subject of this same OMB
clearance for food additive petitions.
On September 29, 2004, OMB approved a new information collection on
food additive petitions submitted by the Center for Veterinary Medicine
(CVM). The terms of clearance for this information collection stated
that, given the interrelatedness of this collection to the information
collected under OMB control number 0910-0016 by the Center for Food
Safety and Applied Nutrition (CFSAN), FDA should consider merging the
two collections. In consultation with CFSAN, CVM has decided not to
merge these two collections, because what was once a food additive
petitions approval (OMB control number 0910-0016), is now also the
approval for affirmation of generally recognized as safe (GRAS) status
(formerly OMB control number 0910-0132), labeling requirements for
color additives (other than hair dyes) and petitions (formerly OMB
control number 0910-0185), electronic submission of food and color
additive petitions (formerly OMB control number 0910-0480), and
substances approved for use in the preparation of meat and poultry
products (formerly OMB control number 0910-0461). Thus, adding one CVM
process to a collection now containing four dissimilar CFSAN processes
is not justifiable any more. Finally, the CVM food additive petition
process stems from a different section of the CFR and the two processes
are handled separately. CVM's food additive petition process relates to
part 571; CFSAN's process relates to 21 CFR part 171. There is no
efficiency in discussing these separate processes in a single
collection of information.
Respondents are expected to be the veterinary feed industry.
FDA estimates the burden of this collection of information as
follows:
The estimated annual burden for this information collection is
18,000 hours.
Food additive petitions submitted to CVM are estimated to fall into
one of two categories of complexity that also can be used to represent
estimates of the information collection burden for food additive
petitions. These include only expected petitions for food additives not
eligible for exemption under new section 409(h) of the act (21 U.S.C.
348(h)).
Under Sec. 571.1(c) moderate category, for a food additive
petition without complex chemistry, manufacturing, efficacy, or safety
issues, the estimated time requirement per petition is approximately
3,000 hours. An average of one petition of this type is received on an
annual basis, resulting in a burden of 3,000 hours.
Under Sec. 571.1(c) complex category, for a food additive petition
with complex chemistry, manufacturing, efficacy, and/or safety issues,
the estimated time requirement per petition is approximately 10,000
hours. An average of one petition of this type is received on an annual
basis, resulting in a burden of 10,000 hours.
Under Sec. 571.6, for a food additive petition amendment, the
estimated time requirement per petition is approximately 1,300 hours.
An average of four petitions of this type are received on an annual
basis, resulting in a burden of 5,200 hours.
In the Federal Register of September 1, 2006 (71 FR 52124), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) moderate category 1 1 1 3,000 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) complex category 1 1 1 10,000 10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.6 2 2 4 1,300 5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 18,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 66543]]
Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19201 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S
