Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient, 16020-16021 [E8-6061]
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16020
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
107.250
2
1
2
120
240
107.260
1
1
1
650
650
Total
12,854
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary
to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities. No
burden has been estimated for the
recordkeeping requirement in § 107.280
because these records are maintained as
a usual and customary part of normal
business activities. Manufacturers keep
infant formula distribution records for
the prescribed period as a matter of
routine business practice.
The reporting burden estimate is
based on agency records, which show
that there are five manufacturers of
infant formula and that there have been,
on average, two infant formula recalls
per year for the past 3 years.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6060 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pwalker on PROD1PC71 with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:52 Mar 25, 2008
Jkt 214001
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.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2008–N–0170]
AGENCY:
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
to FDA information upon which the
manufacturer or distributor 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 May 27, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 at least 75
days before the introduction or delivery
for introduction into interstate
commerce of a dietary supplement that
contains a new dietary ingredient, a
manufacturer or distributor of dietary
supplements or of a new dietary
ingredient is to submit to FDA (as
delegate for the Secretary of Health and
Human Services) information upon
which the manufacturer or distributor
has based its conclusion that a dietary
supplement containing a new dietary
ingredient will reasonably be expected
to be safe. Part 190 (21 CFR part 190)
implements these statutory provisions.
Section 190.6(a) requires each
E:\FR\FM\26MRN1.SGM
26MRN1
16021
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
manufacturer or distributor of a dietary
supplement containing a new dietary
ingredient, or of a new dietary
ingredient, to submit to the Office of
Nutrition, 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
supplement containing a new dietary
ingredient is in full compliance with the
act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
190.6
1 There
71
Total Annual
Responses
1
Hours per
Response
71
Total Hours
20
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.
The estimated number of premarket
notifications and hours per response is
an average based on the agency’s
experience with notifications received
during the last 3 years (i.e., 2005, 2006,
and 2007), and information from firms
that have submitted recent premarket
notifications.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
pwalker on PROD1PC71 with NOTICES
Annual Frequency
per Response
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6061 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
18:52 Mar 25, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0173]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
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 information collection requirements
for appeals of science-based decisions
above the division level at the Center for
Veterinary Medicine (CVM).
DATES: Submit written or electronic
comments on the collection of
information by May 27, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16020-16021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6061]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0170]
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 to FDA information upon which the manufacturer
or distributor 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 May 27, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient, a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit to FDA (as delegate for the Secretary of Health
and Human Services) information upon which the manufacturer or
distributor has based its conclusion that a dietary supplement
containing a new dietary ingredient will reasonably be expected to be
safe. Part 190 (21 CFR part 190) implements these statutory provisions.
Section 190.6(a) requires each
[[Page 16021]]
manufacturer or distributor of a dietary supplement containing a new
dietary ingredient, or of a new dietary ingredient, to submit to the
Office of Nutrition, 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
supplement containing a new dietary ingredient is in full compliance
with the act.
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 per Response Responses 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.
The estimated number of premarket notifications and hours per
response is an average based on the agency's experience with
notifications received during the last 3 years (i.e., 2005, 2006, and
2007), and information from firms that have submitted recent premarket
notifications.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6061 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
