Small Entity Compliance Guide: Bottled Water: Arsenic; Availability, 19972-19973 [E9-9870]
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19972
Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0195]
Small Entity Compliance Guide:
Bottled Water: Uranium; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bottled Water: Uranium—
Small Entity Compliance Guide’’ for a
direct final rule published in the
Federal Register of March 3, 2003. This
small entity compliance guide (SECG) is
intended to set forth in plain language
the requirements of the regulation and
to help small businesses understand the
regulation.
DATES: Submit written or electronic
comments on the SECG at any time.
ADDRESSES: Submit written requests for
single copies of the SECG to the
Division of Plant and Dairy Food Safety
(HFS–317), Office of Food Safety, Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, or fax your request to 301–436–
2651. Send one self-addressed adhesive
label to assist that office in processing
your request.
Submit written comments on the
SECG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments on the SECG to
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Paul
South, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–1640.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 3,
2003 (68 FR 9873), FDA issued a direct
final rule amending its bottled water
quality standard regulations by
establishing an allowable level for the
contaminant uranium. FDA also
retained the existing allowable levels for
combined radium-226/-228, gross alpha
particle radioactivity, and beta particle
and photon radioactivity. On June 9,
2003, FDA confirmed the effective date
of December 8, 2003, for the direct final
rule (68 FR 34272).
VerDate Nov<24>2008
15:35 Apr 29, 2009
Jkt 217001
FDA examined the economic
implications of the direct final rule as
required by the Regulatory Flexibility
Act (5. U.S.C. 601–612) and determined
that the rule would have a significant
economic impact on a substantial
number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121), FDA is making
available this SECG stating in plain
language the legal requirements of the
March 3, 2003, direct final rule set forth
in 21 CFR part 165 concerning the
contaminant uranium.
FDA is issuing this SECG as level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bottled Water: Arsenic—Small
Entity Compliance Guide’’ for a final
rule published in the Federal Register
of June 9, 2005. This small entity
compliance guide (SECG) is intended to
set forth in plain language the
requirements of the regulation and to
help small businesses understand the
regulation.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The SECG
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
DATES: Submit written or electronic
comments on the SECG at any time.
ADDRESSES: Submit written requests for
single copies of the SECG to the
Division of Plant and Dairy Food Safety
(HFS–317), Office of Food Safety, Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, or fax your request to 301–436–
2651. Send one self-addressed adhesive
label to assist that office in processing
your request.
Submit written comments on the
SECG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments on the SECG to
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Paul
South, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–1640.
SUPPLEMENTARY INFORMATION:
III. Electronic Access
I. Background
Persons with access to the Internet
may obtain the document at https://
www.cfsan.fda.gov/guidance.html.
In the Federal Register of June 9, 2005
(70 FR 33694), FDA issued a final rule
amending its bottled water quality
standard regulations by revising the
existing allowable level for the
contaminant arsenic. This final rule
became effective on January 23, 2006.
FDA examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5.
U.S.C. 601–612) and determined that
the rule would have a significant
economic impact on a substantial
number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121), FDA is making
available this SECG stating in plain
language the legal requirements of the
June 9, 2006, final rule set forth in 21
CFR part 165 concerning the
contaminant arsenic.
II. Comments
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9867 Filed 4–29–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0196]
Small Entity Compliance Guide:
Bottled Water: Arsenic; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\30APN1.SGM
30APN1
Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices
FDA is issuing this SECG as level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c) (2)). The SECG represents the
agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The SECG
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.cfsan.fda.gov/guidance.html.
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9870 Filed 4–29–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0198]
Small Entity Compliance Guide:
Cochineal Extract and Carmine:
Declaration by Name on the Label of
All Foods and Cosmetic Products That
Contain These Color Additives;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Cochineal Extract and
Carmine: Declaration by Name on the
Label of All Foods and Cosmetic
Products That Contain These Color
Additives—Small Entity Compliance
Guide.’’ The small entity compliance
guide (SECG) is being issued for a final
VerDate Nov<24>2008
15:35 Apr 29, 2009
Jkt 217001
rule published in the Federal Register
of January 5, 2009, and it is intended to
set forth in plain language the
requirements of the regulation and to
help small businesses understand the
regulation.
DATES: Submit written or electronic
comments on the SECG at any time.
ADDRESSES: Submit written requests for
single copies of the SECG to the
Division of Petition Review, Office of
Food Additive Safety (HFS–265), Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, or FAX your request to 301–436–
2972. Send one self-addressed adhesive
label to assist that office in processing
your request. Submit written comments
on the SECG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments on the SECG to
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT:
James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1303.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 5,
2009 (74 FR 207), FDA issued a final
rule requiring the declaration of
cochineal extract and carmine by name
on the label of all foods and cosmetic
products that contain these color
additives. This final rule becomes
effective January 5, 2011.
FDA examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and determined that
the final rule may have a significant
economic impact on a substantial
number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121), FDA is making
available this SECG stating in plain
language the legal requirements of the
January 5, 2009, final rule set forth in 21
CFR parts 73 and 101 concerning
cochineal extract and carmine.
FDA is issuing this SECG as level 2
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
19973
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this SECG. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The SECG and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.cfsan.fda.gov/guidance.html.
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9868 Filed 4–29–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Statement of Delegation of Authority
Notice is hereby given that I have
delegated to the Director, National
Institutes of Health (NIH), the
authorities added to the Public Health
Service Act by Section 801 of Public
Law 110–85, the Food and Drug
Administration Amendments Act of
2007, 42 U.S.C. 282(j), as amended,
pertaining to the expansion of the
Clinical Trial Registry and Results Data
Bank described therein. Specifically, the
Director is delegated the following
authorities:
1. 402(j)(2)(A)(ii)(IV), 42 U.S.C.
282(j)(2)(A)(ii)(IV): The Secretary may
make publicly available certain
administrative data collected for the
registry, as necessary.
2. 402(j)(3)(A)(i), 42 U.S.C.
282(j)(3)(A)(i): To ensure that the Data
Bank includes links to results
information for those trials that form the
primary basis for an efficacy claim or
are performed after clearance or
approval of the drug or device, under 42
U.S.C. 282(j)(3)(A)(i).
3. 402(j)(3)(A)(ii)(I), 42 U.S.C.
282(j)(3)(A)(ii)(I): To ensure that the
Data Bank includes links to specified
FDA information.
E:\FR\FM\30APN1.SGM
30APN1
Agencies
[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Pages 19972-19973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9870]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0196]
Small Entity Compliance Guide: Bottled Water: Arsenic;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Bottled Water:
Arsenic--Small Entity Compliance Guide'' for a final rule published in
the Federal Register of June 9, 2005. This small entity compliance
guide (SECG) is intended to set forth in plain language the
requirements of the regulation and to help small businesses understand
the regulation.
DATES: Submit written or electronic comments on the SECG at any time.
ADDRESSES: Submit written requests for single copies of the SECG to the
Division of Plant and Dairy Food Safety (HFS-317), Office of Food
Safety, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to 301-436-2651. Send one self-addressed adhesive label to
assist that office in processing your request.
Submit written comments on the SECG to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the SECG
to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1640.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 9, 2005 (70 FR 33694), FDA issued a
final rule amending its bottled water quality standard regulations by
revising the existing allowable level for the contaminant arsenic. This
final rule became effective on January 23, 2006.
FDA examined the economic implications of the final rule as
required by the Regulatory Flexibility Act (5. U.S.C. 601-612) and
determined that the rule would have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Public Law 104-
121), FDA is making available this SECG stating in plain language the
legal requirements of the June 9, 2006, final rule set forth in 21 CFR
part 165 concerning the contaminant arsenic.
[[Page 19973]]
FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c) (2)). The SECG
represents the agency's current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The SECG and received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.cfsan.fda.gov/guidance.html.
Dated: April 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9870 Filed 4-29-09; 8:45 am]
BILLING CODE 4160-01-S