Notice of Approval of Original Abbreviated New Animal Drug Application; Pyrantel Pamoate Suspension, 70412-70413 [E6-20399]
Download as PDF
<![CDATA[
70412
Federal Register / Vol. 71, No. 232 / Monday, December 4, 2006 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Cosmetic Labeling Regulations—21 CFR
Part 701
The Federal Food, Drug, and Cosmetic
Act (the act) and the Fair Packaging and
Labeling Act (the FPLA) require that
cosmetic manufacturers, packers, and
distributors disclose information about
themselves or their products on the
labels or labeling of their products.
Sections 201, 502, 601, 602, 603, 701,
and 704 of the act (21 U.S.C. 321, 352,
361, 362, 363, 371, and 374) and
sections 4 and 5 of the FPLA (15 U.S.C.
1453 and 1454) provide authority to
FDA to regulate the labeling of cosmetic
products. Failure to comply with the
requirements for cosmetic labeling may
render a cosmetic adulterated under
section 601 of the act or misbranded
under section 602 of the act.
FDA’s cosmetic labeling regulations
are published in part 701 (21 CFR part
701). Four of the cosmetic labeling
regulations have information collection
provisions. Section 701.3 requires the
label of a cosmetic product to bear a
declaration of the ingredients in
descending order of predominance.
Section 701.11 requires the principal
display panel of a cosmetic product to
bear a statement of the identity of the
product. Section 701.12 requires the
label of a cosmetic product to specify
the name and place of business of the
manufacturer, packer, or distributor.
Section 701.13 requires the label of a
cosmetic product to declare the net
quantity of contents of the product.
FDA’s cosmetic labeling regulations,
as published in the Federal Register on
March 15, 1974 (39 FR 10054 at 10056),
and subsequently amended, most
recently on March 17, 1999 (64 FR
13254 at 13297), remain unchanged by
this notice. FDA is publishing this
notice in compliance with the PRA.
This notice does not represent any new
regulatory initiative.
In the Federal Register of January 18,
2006 (71 FR 2947), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
701.3
1,518
21
31,600
1
31,600
701.11
1,518
24
36,340
1
36,340
701.12
1,518
24
36,340
1
36,340
701.13
1,518
24
36,340
1
36,340
Total
mstockstill on PROD1PC61 with NOTICES
1There
140,620
are no capital costs or operating and maintenance costs associated with this collection of information.
The hour burden is the additional or
incremental time that establishments
need to design and print labeling that
includes the following required
elements: A declaration of ingredients
in decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments need to design
labels because they increase the number
of label elements that establishments
must take into account when designing
labels. These requirements do not
generate any recurring burden per label
because establishments must already
print and affix labels to cosmetic
products as part of normal business
practices.
According to the 2001 census, there
are 1,518 cosmetic product
establishments in the United States
(U.S. Census Bureau, https://
www.census.gov/epcd/susb/2001/us/
US32562.HTM). FDA calculates label
design costs based on stock keeping
units (SKUs) because each SKU has a
unique product label. Based on data
available to the agency and on
communications with industry, FDA
VerDate Aug<31>2005
11:51 Dec 01, 2006
Jkt 211001
estimates that cosmetic establishments
offered 94,800 SKUs for retail sale in
2005. This corresponds to an average of
62 SKUs per establishment.
One of the four provisions that FDA
discusses in this information collection,
§ 701.3, applies only to cosmetic
products offered for retail sale.
However, the other three provisions,
§§ 701.11, 701.12, and 701.13, apply to
all cosmetic products, including nonretail professional-use-only products.
FDA estimates that including
professional-use-only cosmetic products
increases the total number of SKUs by
15 percent to 109,020. This corresponds
to an average of 72 SKUs per
establishment.
Finally, based on the agency’s
experience with other products, FDA
estimates that cosmetic establishments
may redesign up to one-third of SKUs
per year. Therefore, FDA estimates that
the annual frequency of response will be
21 (31,600 SKUs) for § 701.3 and 24
each (36,340 SKUs) for §§ 701.11,
701.12, and 701.13.
FDA estimates that each of the
required label elements may add
approximately 1 hour to the label design
process. FDA bases this estimate on the
hour burdens the agency has previously
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
estimated for food, drug, and medical
device labeling and on the agency’s
knowledge of cosmetic labeling.
Therefore, FDA estimates that the total
hour burden on members of the public
for this information collection is
140,620 hours per year.
Dated: November 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–20478 Filed 12–01–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Notice of Approval of Original
Abbreviated New Animal Drug
Application; Pyrantel Pamoate
Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved an original
abbreviated new animal drug
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 71, No. 232 / Monday, December 4, 2006 / Notices
application (ANADA) filed by First
Priority, Inc. The ANADA provides for
oral use of pyrantel pamoate suspension
in horses and ponies as an over-thecounter (OTC) animal drug product for
the removal and control of various
internal parasites.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
First
Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200–445
providing for oral use of PRIMEX
(pyrantel pamoate) Horse Wormer in
horses and ponies as an OTC animal
drug product for the removal and
control of various internal parasites.
First Priority, Inc.’s, PRIMEX Horse
Wormer is approved as a generic copy
of Pfizer, Inc.’s, PAMOBAN Horse
Wormer, approved under NADA 91–
739. In accordance with section 512(i) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(i)) and part
514 (21 CFR part 514), in §§ 514.105(a)
and 514.106(a), the Center for
Veterinary Medicine is providing notice
that this ANADA is approved as of
November 3, 2006. The basis of
approval is discussed in the freedom of
information summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
mstockstill on PROD1PC61 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–20399 Filed 11–01–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
11:51 Dec 01, 2006
Jkt 211001
DEPARTMENT OF HOMELAND
SECURITY
National Communications System
[Docket No. NCS–2006–0009]
National Security Telecommunications
Advisory Committee
National Communications
System, DHS.
ACTION: Notice of Partially Closed
Advisory Committee Meeting
AGENCY:
SUMMARY: The President’s National
Security Telecommunications Advisory
Committee (NSTAC) will meet in a
partially closed session.
DATES: Tuesday, December 19, 2006,
from 1 p.m. until 4 p.m.
ADDRESSES: The meeting will take place
at the U.S. Chamber of Commerce, 1615
H St. NW., Washington, DC. If you
desire to submit comments, they must
be submitted by December 12, 2006.
Comments must be identified by Docket
Number NCS–2006–0009 and may be
submitted by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: NSTAC1@dhs.gov. Include
docket number in the subject line of the
message.
• Mail: Office of the Manager,
National Communications System (N5),
Department of Homeland Security,
Washington, DC, 20529.
• Fax: 866–466–5370.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and NCS–2006–
0009, the docket number for this action.
Comments received will be posted
without alteration at
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received by the NSTAC, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ms.
Kiesha Gebreyes, Chief, Industry
Operations Branch at (703) 235–5525, email: Kiesha.Gebreyes@dhs.gov or write
the Deputy Manager, National
Communications System, Department of
Homeland Security, CS&T/NCS/N5.
SUPPLEMENTARY INFORMATION: The
NSTAC advises the President on issues
and problems related to implementing
national security and emergency
preparedness telecommunications
policy. Notice of this meeting is given
under the Federal Advisory Committee
Act (FACA), Pub. L. 92–463, as
amended (5 U.S.C. App.1 et seq.).
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
70413
Between 1 p.m. and 3 p.m., the
NSTAC will receive comments from
government stakeholders, discuss the
work of the NSTAC’s Emergency
Communications and Interoperability
Task Force (ECITF), and discuss the
work of the Telecommunications and
Electric Power Interdependency Task
Force (TEPITF). This portion of the
meeting will be open to the public.
Between 3 p.m. and 4 p.m., the
committee will discuss the Global
Infrastructure Resiliency (GIR) Report.
This portion of the meeting will be
closed to the public.
Basis for Closure: The GIR discussion
will likely involve sensitive
infrastructure information concerning
system threats and explicit physical/
cyber vulnerabilities related to current
communications capabilities. Public
disclosure of such information would
heighten awareness of potential
vulnerabilities and increase the
likelihood of exploitation by terrorists
or other motivated adversaries. Pursuant
to Section 10(d) of the Federal Advisory
Committee Act, Public Law 92–463, as
amended (5 U.S.C. App. 1 et seq.), the
Department has determined that this
discussion will concern matters which,
if disclosed, would be likely to frustrate
significantly the implementation of a
proposed agency action. Accordingly,
this portion of the meeting will be
closed to the public pursuant to the
authority set forth in 5 U.S.C.
552b(c)(9)(B).
Information on Services for
Individuals With Disabilities: For
information on facilities or services for
individuals with disabilities, or to
request special assistance at the
meeting, contact Kiesha Gebreyes as
soon as possible.
Dated: November 20, 2006.
Peter M. Fonash,
Deputy Manager National Communications
System.
[FR Doc. E6–20403 Filed 12–1–06; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2006–0063]
Privacy Act; Background Check
Services System of Records
Privacy Office, Department of
Homeland Security.
ACTION: Notice of Privacy Act system of
records notice.
AGENCY:
SUMMARY: Pursuant to the Privacy Act of
1974, the Department of Homeland
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Notices]
[Pages 70412-70413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Notice of Approval of Original Abbreviated New Animal Drug
Application; Pyrantel Pamoate Suspension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice
that it has approved an original abbreviated new animal drug
[[Page 70413]]
application (ANADA) filed by First Priority, Inc. The ANADA provides
for oral use of pyrantel pamoate suspension in horses and ponies as an
over-the-counter (OTC) animal drug product for the removal and control
of various internal parasites.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-445 providing for oral use of PRIMEX
(pyrantel pamoate) Horse Wormer in horses and ponies as an OTC animal
drug product for the removal and control of various internal parasites.
First Priority, Inc.'s, PRIMEX Horse Wormer is approved as a generic
copy of Pfizer, Inc.'s, PAMOBAN Horse Wormer, approved under NADA 91-
739. In accordance with section 512(i) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(i)) and part 514 (21 CFR part
514), in Sec. Sec. 514.105(a) and 514.106(a), the Center for
Veterinary Medicine is providing notice that this ANADA is approved as
of November 3, 2006. The basis of approval is discussed in the freedom
of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20399 Filed 11-01-06; 8:45 am]
BILLING CODE 4160-01-S
