Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient, 6444-6445 [05-2207]
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Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
TRANS #
Acquiring
Acquired
Entities
20050489 .........................
Highland Capital Partners VI .............
Michael Mann ....................................
Rare Domains.com, LLC.
Rare Names, LLC.
Transactions Granted Early Termination—01/21/2005
20050487 .........................
Cofra Holding AG ..............................
FOR FURTHER INFORMATION CONTACT:
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–2276 Filed 2–4–05; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
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 procedure by which a manufacturer
or distributor of dietary supplements or
of a new dietary ingredient is to submit
information to FDA upon which it has
based its conclusion that a dietary
supplement containing a new dietary
ingredient will reasonably be expected
to be safe.
DATES: Submit written or electronic
comments on the collection of
information by April 8, 2005.
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
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
ADDRESSES:
Sandra M. Peay, Contact Representative,
or Renee Hallman, Case Management
Assistant.
Federal Trade Commission, Premerger
Notification Office, Bureau of
Competition, Room H–303, Washington,
DC 20580, (202) 326–3100.
AGENCY:
Aaron D. Spencer ..............................
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Uno Restaurant Holdings Corporation.
of automated collection techniques,
when appropriate, and other forms of
information technology.
Premarket Notification for a New
Dietary Ingredient—21 CFR 190.6
(OMB Control Number 0910–0330)—
Extension
Section 413(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 350b(a)) provides that a
manufacturer or distributor of dietary
supplements or of a new dietary
ingredient is to submit information to
FDA (as delegate for the Secretary of
Health and Human Services) upon
which it has based its conclusion that a
dietary supplement containing a new
dietary ingredient will reasonably be
expected to be safe at least 75 days
before the introduction or delivery for
introduction into interstate commerce of
a dietary supplement that contains a
new dietary ingredient. FDA’s
regulations at part 190, subpart B (21
CFR part 190, subpart B) implement
these statutory provisions. Section
190.6(a) requires each manufacturer or
distributor of a dietary supplement
containing a new dietary ingredient, or
of a new dietary ingredient, to submit to
the Office of Nutritional Products,
Labeling, and Dietary Supplements
notification of the basis for their
conclusion that said supplement or
ingredient will reasonably be expected
to be safe. Section 190.6(b) requires that
the notification include the following:
(1) The complete name and address of
the manufacturer or distributor, (2) the
name of the new dietary ingredient, (3)
a description of the dietary supplements
that contain the new dietary ingredient,
and (4) the history of use or other
evidence of safety establishing that the
dietary ingredient will reasonably be
expected to be safe.
The notification requirements
described previously are designed to
enable FDA to monitor the introduction
into the food supply of new dietary
ingredients and dietary supplements
that contain new dietary ingredients, in
order to protect consumers from unsafe
dietary supplements. FDA uses the
information collected under these
regulations to help ensure that a
manufacturer or distributor of a dietary
E:\FR\FM\07FEN1.SGM
07FEN1
Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
supplement containing a new dietary
6445
ingredient is in full compliance with the
act.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency
per Response
No. of Respondents
190.6
71
1There
Total Annual Responses
1
Hours per Response
71
1,420
are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be
minimal burden on the industry to
generate data to meet the requirements
of the premarket notification program
because the agency is requesting only
that information that the manufacturer
or distributor should already have
developed to satisfy itself that a dietary
supplement containing a new dietary
ingredient is in full compliance with the
act. However, the agency estimates that
extracting and summarizing the relevant
information from the company’s files,
and presenting it in a format that will
meet the requirements of section 413 of
the act will require a burden of
approximately 20 hours of work per
submission.
This estimate is based on the annual
average number of premarket
notifications FDA received during the
last 3 years (i.e., 2002 to 2004), which
was 47. Forty-seven represents 24 more
notifications than the agency received as
an annual average during the previous
3-year period (i.e., 1999 to 2001).
Therefore, FDA anticipates a similar
upward trend will be seen in the annual
average number of notifications the
agency receives during 2005 to 2007,
which is estimated to be 71.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2207 Filed 2–4–05; 8:45 am]
that a collection of information entitled
‘‘Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 19, 2004 (69 FR
42999), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0045. The
approval expires on December 31, 2007.
A copy of the supporting statement for
this information collection is available
on the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2296 Filed 2–4–05; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. 2004N–0093]
[Docket No. 2005N–0032]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Registration of Producers of Drugs
and Listing of Drugs in Commercial
Distribution
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
20
Total Hours
AGENCY:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00039
Fmt 4703
Sfmt 4703
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
reporting and recordkeeping
requirements for firms that process
acidified foods and thermally processed
low-acid foods in hermetically sealed
containers.
DATES: Submit written or electronic
comments on the collection of
information by April 8, 2005.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. 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,
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6444-6445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2207]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0031]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification for a New Dietary Ingredient
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 procedure by which a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit information to FDA upon which it has based its
conclusion that a dietary supplement containing a new dietary
ingredient will reasonably be expected to be safe.
DATES: Submit written or electronic comments on the collection of
information by April 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.
Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (OMB
Control Number 0910-0330)--Extension
Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 350b(a)) provides that a manufacturer or distributor of
dietary supplements or of a new dietary ingredient is to submit
information to FDA (as delegate for the Secretary of Health and Human
Services) upon which it has based its conclusion that a dietary
supplement containing a new dietary ingredient will reasonably be
expected to be safe at least 75 days before the introduction or
delivery for introduction into interstate commerce of a dietary
supplement that contains a new dietary ingredient. FDA's regulations at
part 190, subpart B (21 CFR part 190, subpart B) implement these
statutory provisions. Section 190.6(a) requires each manufacturer or
distributor of a dietary supplement containing a new dietary
ingredient, or of a new dietary ingredient, to submit to the Office of
Nutritional Products, Labeling, and Dietary Supplements notification of
the basis for their conclusion that said supplement or ingredient will
reasonably be expected to be safe. Section 190.6(b) requires that the
notification include the following: (1) The complete name and address
of the manufacturer or distributor, (2) the name of the new dietary
ingredient, (3) a description of the dietary supplements that contain
the new dietary ingredient, and (4) the history of use or other
evidence of safety establishing that the dietary ingredient will
reasonably be expected to be safe.
The notification requirements described previously are designed to
enable FDA to monitor the introduction into the food supply of new
dietary ingredients and dietary supplements that contain new dietary
ingredients, in order to protect consumers from unsafe dietary
supplements. FDA uses the information collected under these regulations
to help ensure that a manufacturer or distributor of a dietary
[[Page 6445]]
supplement containing a new dietary ingredient is in full compliance
with the act.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
21 CFR Section No. of Respondents per Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6 71 1 71 20 1,420
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be minimal burden on the
industry to generate data to meet the requirements of the premarket
notification program because the agency is requesting only that
information that the manufacturer or distributor should already have
developed to satisfy itself that a dietary supplement containing a new
dietary ingredient is in full compliance with the act. However, the
agency estimates that extracting and summarizing the relevant
information from the company's files, and presenting it in a format
that will meet the requirements of section 413 of the act will require
a burden of approximately 20 hours of work per submission.
This estimate is based on the annual average number of premarket
notifications FDA received during the last 3 years (i.e., 2002 to
2004), which was 47. Forty-seven represents 24 more notifications than
the agency received as an annual average during the previous 3-year
period (i.e., 1999 to 2001). Therefore, FDA anticipates a similar
upward trend will be seen in the annual average number of notifications
the agency receives during 2005 to 2007, which is estimated to be 71.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2207 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S
