Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 16021-16022 [E8-6065]
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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
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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
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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:
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
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.
Appeals of Science-Based Decisions
Above the Division Level at the Center
for Veterinary Medicine—21 CFR Part
10.75 (OMB Control Number 0910–
0566)—Extension
CVM’s ‘‘Guidance for Industry #79—
Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ describes the process by
which CVM formally resolves disputes
relating to scientific controversies. A
scientific controversy involves issues
concerning a specific product regulated
by CVM related to matters of technical
expertise and requires specialized
education, training, or experience to be
understood and resolved. Further, the
guidance details information on how the
agency intends to interpret and apply
provisions of the existing regulations
regarding internal agency review of
decisions. In addition, the guidance
outlines the established recommended
procedures for persons who are
applicants, including sponsor
applicants or manufacturers, for animal
drugs or other products regulated by
CVM, that wish to submit a request for
review of a scientific dispute. When an
applicant has a scientific disagreement
and a written decision by CVM, the
applicant may submit a request for
review of that decision by following the
established agency channels of
supervision for review.
Respondents to this collection of
information are applicants that wish to
submit a request for review of a
scientific dispute.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
10.75
2
1There
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6065 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Anesthetic and Life Support Drugs
Advisory Committee; Notice of Meeting
pwalker on PROD1PC71 with NOTICES
Total Annual
Responses
4
Hours per
Response
8
Total Hours
10
80
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting
burden is based on CVM’s experience
over the past 3 years in handling formal
appeals for scientific disputes. The
number of respondents multiplied by
the annual frequency of response equals
the total annual responses. The number
of hours per response is based on
discussions with industry and may vary
depending on the complexity of the
issue(s) involved and the duration of the
appeal process.
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.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Annual Frequency
per Response
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Aug<31>2005
18:52 Mar 25, 2008
Jkt 214001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anesthetic and
Life Support Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 7, 2008, from 8 a.m. to 4:30
p.m.
Location: Holiday Inn, The Ballrooms,
Two Montgomery Village Ave.,
Gaithersburg, MD, 301–948–8900.
Contact Person: Teresa Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane,
Rm. 1093), Rockville, MD 20857, 301–
827–7001, FAX: 301–827–6776, e-mail:
Teresa.Watkins@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), code
3014512529. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On May 7, 2008, the
committee will discuss new drug
PO 00000
Frm 00058
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application (NDA) 22–244, fospropofol
disodium injection (35 milligrams/
milliliter) (proposed tradename
Aquavan), MGI Pharma, Inc., for the
proposed indication of sedation in adult
patients undergoing diagnostic or
therapeutic procedures.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 23, 2008. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 15, 2008. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
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]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16021-16022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6065]
-----------------------------------------------------------------------
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 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
[[Page 16022]]
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.
Appeals of Science-Based Decisions Above the Division Level at the
Center for Veterinary Medicine--21 CFR Part 10.75 (OMB Control Number
0910-0566)--Extension
CVM's ``Guidance for Industry 79--Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by the
Center for Veterinary Medicine'' describes the process by which CVM
formally resolves disputes relating to scientific controversies. A
scientific controversy involves issues concerning a specific product
regulated by CVM related to matters of technical expertise and requires
specialized education, training, or experience to be understood and
resolved. Further, the guidance details information on how the agency
intends to interpret and apply provisions of the existing regulations
regarding internal agency review of decisions. In addition, the
guidance outlines the established recommended procedures for persons
who are applicants, including sponsor applicants or manufacturers, for
animal drugs or other products regulated by CVM, that wish to submit a
request for review of a scientific dispute. When an applicant has a
scientific disagreement and a written decision by CVM, the applicant
may submit a request for review of that decision by following the
established agency channels of supervision for review.
Respondents to this collection of information are applicants that
wish to submit a request for review of a scientific dispute.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75 2 4 8 10 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting burden is based on CVM's experience
over the past 3 years in handling formal appeals for scientific
disputes. The number of respondents multiplied by the annual frequency
of response equals the total annual responses. The number of hours per
response is based on discussions with industry and may vary depending
on the complexity of the issue(s) involved and the duration of the
appeal process.
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. E8-6065 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
