Combe, Inc.; Filing of Color Additive Petition, 10035 [E8-3416]
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10035
Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Activity
Develop documentation process
1There
1
Dated: February 15, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–3415 Filed 2–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–C–0098]
Combe, Inc.; Filing of Color Additive
Petition
AGENCY:
Food and Drug Administration,
HHS.
rfrederick on PROD1PC67 with NOTICES
Total Annual
Records
1
Hours per
Record
1
Total Hours
16
16
are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual
recordkeeping burden, FDA estimated
that at least 90 percent of firms maintain
documentation, such as packing codes,
batch records, and inventory records, as
part of their basic food production or
import operations. Therefore, the
recordkeeping burden was calculated as
the time required for the 10 percent of
firms that may not be currently
maintaining this documentation to
develop and maintain documentation,
such as batch records and inventory
records. In previous information
collection requests, this recordkeeping
burden was estimated to be 16 hours.
Although FDA estimates that only 1 out
of 10 firms will not be currently
maintaining the necessary
documentation, to avoid counting the
recordkeeping burden for the one
submission per year as zero, FDA has
retained its prior estimate of 16 hours
for the recordkeeping burden.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
ACTION:
Annual Frequency
per Recordkeeping
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Combe, Inc., has filed a petition
proposing that the color additive
regulations be amended to increase the
permitted use level of bismuth citrate as
a color additive in cosmetics intended
for coloring hair on the scalp.
VerDate Aug<31>2005
14:34 Feb 22, 2008
Jkt 214001
Submit written or electronic
comments on the petitioner’s
environmental assessment by March 26,
2008.
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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1264.
SUPPLEMENTARY INFORMATION: Under
section 721e(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379e(d)(1)), notice is given that a color
additive petition (CAP 8C0286) has been
filed by Combe, Inc., c/o EAS
Consulting Group, LLC, 1940 Duke St.,
suite 200, Alexandria, VA 22314. The
petition proposes to amend the color
additive regulations in § 73.2110
Bismuth citrate (21 CFR 73.2110) to
increase the permitted use level of
bismuth citrate as a color additive in
cosmetics intended for coloring hair on
the scalp.
The potential environmental impact
of this action is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see ADDRESSES) for public review and
comment.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
DATES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the agency finds
that an environmental impact statement
is not required and this petition results
in a regulation, the notice of availability
of the agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: February 15, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E8–3416 Filed 2–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0060] (formerly
Docket No. 1998D–0021)
Guidance for Industry: Container and
Closure System Integrity Testing in
Lieu of Sterility Testing as a
Component of the Stability Protocol for
Sterile Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Container and
Closure System Integrity Testing in Lieu
of Sterility Testing as a Component of
the Stability Protocol for Sterile
Products,’’ dated February 2008. The
guidance document provides
recommendations to sponsors for using
methods other than sterility testing to
confirm the integrity of container and
closure systems as part of stability
testing for sterile biological products,
human and veterinary drugs, and
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 73, Number 37 (Monday, February 25, 2008)]
[Notices]
[Page 10035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3416]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-C-0098]
Combe, Inc.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Combe, Inc., has filed a petition proposing that the color additive
regulations be amended to increase the permitted use level of bismuth
citrate as a color additive in cosmetics intended for coloring hair on
the scalp.
DATES: Submit written or electronic comments on the petitioner's
environmental assessment by March 26, 2008.
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.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264.
SUPPLEMENTARY INFORMATION: Under section 721e(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), notice is given
that a color additive petition (CAP 8C0286) has been filed by Combe,
Inc., c/o EAS Consulting Group, LLC, 1940 Duke St., suite 200,
Alexandria, VA 22314. The petition proposes to amend the color additive
regulations in Sec. 73.2110 Bismuth citrate (21 CFR 73.2110) to
increase the permitted use level of bismuth citrate as a color additive
in cosmetics intended for coloring hair on the scalp.
The potential environmental impact of this action is being
reviewed. To encourage public participation consistent with regulations
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
the agency is placing the environmental assessment submitted with the
petition that is the subject of this notice on public display at the
Division of Dockets Management (see ADDRESSES) for public review and
comment.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. FDA will also place on public display any amendments
to, or comments on, the petitioner's environmental assessment without
further announcement in the Federal Register. If, based on its review,
the agency finds that an environmental impact statement is not required
and this petition results in a regulation, the notice of availability
of the agency's finding of no significant impact and the evidence
supporting that finding will be published with the regulation in the
Federal Register in accordance with 21 CFR 25.51(b).
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: February 15, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. E8-3416 Filed 2-22-08; 8:45 am]
BILLING CODE 4160-01-S
