Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination, 73009-73010 [05-23747]
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Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
Dated: December 1, 2005.
Joan Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7040 Filed 12–7–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0457]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of a Claim
for Generally Recognized as Safe
Exemption Based on a Generally
Recognized as Safe Determination
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
[Docket No. 2005N–0186]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
State Enforcement Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘State Enforcement Notifications’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
In the
Federal Register of September 14, 2005
(70 FR 54393), 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 0910–0275. The
approval expires on November 30, 2008.
A copy of the supporting statement for
this information collection is available
on the Internet at ‘‘https://www.fda.gov/
ohrms/dockets’’.
SUPPLEMENTARY INFORMATION:
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23744 Filed 12–7–05; 8:45 am]
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Food and Drug Administration,
HHS.
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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 procedures used for submitting a
Generally Recognized as Safe (GRAS)
notice stating that a particular use of a
substance is not subject to the premarket
approval requirements of the Federal
Food, Drug, and Cosmetic Act (the act).
DATES: Submit written or electronic
comments on the collection of
information by February 6, 2006.
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
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73009
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.
Notice of a Claim for GRAS Exemption
Based on a GRAS Determination—21
CFR 170.36 and 570.36 (OMB Control
Number 0910–0342)—Extension
Section 409 of the act (21 U.S.C. 348)
establishes a premarket approval
requirement for ‘‘food additives;’’
section 201(s) of the act (21 U.S.C.
321(s)) provides an exemption from the
definition of ‘‘food additive’’ and thus
from the premarket approval
requirement, for uses of substances that
are GRAS by qualified experts. FDA is
proposing a voluntary procedure
whereby members of the food industry
who determine that use of a substance
satisfies the statutory exemption may
notify FDA of that determination. The
notice would include a detailed
summary of the data and information
that support the GRAS determination,
and the notifier would maintain a
record of such data and information.
FDA would make the information
describing the GRAS claim, and the
agency’s response to the notice,
available in a publicly accessible file;
the entire GRAS notice would be
publicly available consistent with the
Freedom of Information Act and other
Federal disclosure statutes.
Description of Respondents:
Manufacturers of Substances Used in
Food and Feed.
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Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
50
10
21 CFR Section
1
1
50
10
150
150
7,500
1,500
9,000
170.36
570.36
Total
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
Hours per
Recordkeeper
Total Hours
50
10
21 CFR Section
1
1
50
10
15
15
750
150
900
170.36(c)(v)
570.36(c)(v)
Total
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting requirement is for a
proposed rule that has not yet been
issued as a final rule. In developing the
proposed rule, FDA solicited input from
representatives of the food industry on
the reporting requirements, but could
not fully discuss with those
representatives the details of the
proposed notification procedure. FDA
received no comments on the agency’s
estimate of the hourly reporting
requirements, and thus has no basis to
revise that estimate at this time. In 1998,
FDA began receiving notices that were
submitted under the terms of the
proposed rule. Since it began receiving
notices, FDA has received 12 in 1998,
23 in 1999, 30 in 2000, 28 in 2001, 26
in 2002, 23 in 2003, 20 in 2004, and 22
to date in 2005, notices annually. To
date, the number of annual notices is
less than FDA’s estimate; however, the
number of annual notices could increase
when the proposed rule becomes final.
FDA received 23 notices in 1999, 30
notices in 2000, 28 notices in 2001, 26
notices in 2002, 23 notices in 2003, and
20 notices in 2004.
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23747 Filed 12–7–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0434]
Draft Guidance for Industry and Food
and Drug Administration; Nucleic Acid
Based In Vitro Diagnostic Devices for
Detection of Microbial Pathogens;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Nucleic Acid Based In Vitro
Diagnostic Devices for Detection of
Microbial Pathogens.’’ This draft
guidance document is being issued to
provide guidance on the types of
information and data to consider when
preparing or reviewing premarket
submissions for nucleic acid based in
vitro diagnostic devices for the
detection of microbial pathogens.
DATES: Submit written or electronic
comments on this draft guidance by
March 8, 2006.
ADDRESSES: Submit written requests for
single copies on a 3.5’’ diskette of the
guidance document entitled ‘‘Nucleic
Acid Based In Vitro Diagnostic Devices
for Detection of Microbial Pathogens’’ to
the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or
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FAX your request to 301–443–8818. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit written comments concerning
this guidance 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.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Roxanne Shively, Center for Devices
and Radiological Health (HFZ–440),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0496 ext. 113.
SUPPLEMENTARY INFORMATION:
I. Background
This draft document is intended to
provide a basic framework for the types
of information and data that we believe
should be addressed in the premarket
review of a nucleic acid based device for
detecting microbial pathogens. This
draft guidance replaces a previously
issued document entitled ‘‘Review
Criteria for Nucleic Acid Amplificationbased in vitro Diagnostic Devices for
Direct Detection of Infectious
Microorganisms’’ (June 1993). The
current draft reflects changes in the
technologies available for nucleic acid
detection, and expanded use in clinical
laboratories. The recommendations
within this draft guidance apply broadly
to premarket review of these in vitro
diagnostic devices for detecting
microbial pathogens. Enzymatic
amplification may or may not be part of
the applied technology.
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[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73009-73010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23747]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0457]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Notice of a Claim for Generally Recognized as Safe
Exemption Based on a Generally Recognized as Safe Determination
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 procedures used for
submitting a Generally Recognized as Safe (GRAS) notice stating that a
particular use of a substance is not subject to the premarket approval
requirements of the Federal Food, Drug, and Cosmetic Act (the act).
DATES: Submit written or electronic comments on the collection of
information by February 6, 2006.
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.
Notice of a Claim for GRAS Exemption Based on a GRAS Determination--21
CFR 170.36 and 570.36 (OMB Control Number 0910-0342)--Extension
Section 409 of the act (21 U.S.C. 348) establishes a premarket
approval requirement for ``food additives;'' section 201(s) of the act
(21 U.S.C. 321(s)) provides an exemption from the definition of ``food
additive'' and thus from the premarket approval requirement, for uses
of substances that are GRAS by qualified experts. FDA is proposing a
voluntary procedure whereby members of the food industry who determine
that use of a substance satisfies the statutory exemption may notify
FDA of that determination. The notice would include a detailed summary
of the data and information that support the GRAS determination, and
the notifier would maintain a record of such data and information. FDA
would make the information describing the GRAS claim, and the agency's
response to the notice, available in a publicly accessible file; the
entire GRAS notice would be publicly available consistent with the
Freedom of Information Act and other Federal disclosure statutes.
Description of Respondents: Manufacturers of Substances Used in
Food and Feed.
[[Page 73010]]
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.36 50 1 50 150 7,500
570.36 10 1 10 150 1,500
Total ............... ..................... ..................... ............... 9,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Hours per
21 CFR Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.36(c)(v) 50 1 50 15 750
570.36(c)(v) 10 1 10 15 150
Total ............... ..................... ..................... ............... 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting requirement is for a proposed rule that has not yet
been issued as a final rule. In developing the proposed rule, FDA
solicited input from representatives of the food industry on the
reporting requirements, but could not fully discuss with those
representatives the details of the proposed notification procedure. FDA
received no comments on the agency's estimate of the hourly reporting
requirements, and thus has no basis to revise that estimate at this
time. In 1998, FDA began receiving notices that were submitted under
the terms of the proposed rule. Since it began receiving notices, FDA
has received 12 in 1998, 23 in 1999, 30 in 2000, 28 in 2001, 26 in
2002, 23 in 2003, 20 in 2004, and 22 to date in 2005, notices annually.
To date, the number of annual notices is less than FDA's estimate;
however, the number of annual notices could increase when the proposed
rule becomes final. FDA received 23 notices in 1999, 30 notices in
2000, 28 notices in 2001, 26 notices in 2002, 23 notices in 2003, and
20 notices in 2004.
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23747 Filed 12-7-05; 8:45 am]
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