Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications, 17986-17987 [E8-6887]
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17986
Federal Register / Vol. 73, No. 64 / Wednesday, April 2, 2008 / Notices
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) involving this device became
effective: July 7, 2000. The applicant
claims that the investigational device
exemption (IDE) required under section
520(g) of the act for human tests to begin
became effective on June 8, 2000.
However, FDA records indicate that the
IDE was determined substantially
complete for clinical studies to have
begun on July 7, 2000, which represents
the IDE effective date.
2. The date an application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): December 26, 2001. The
applicant claims December 21, 2001, as
the date the premarket approval
application (PMA) for ACRYSOF (PMA
P930014/S009) was initially submitted.
However, FDA records indicate that
PMA P930014/S009 was submitted on
December 26, 2001.
3. The date the application was
approved: June 24, 2003. FDA has
verified the applicant’s claim that PMA
P930014/S009 was approved on June
24, 2003.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 832 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by June 2, 2008.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 29, 2008. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Aug<31>2005
15:36 Apr 01, 2008
Jkt 214001
Dated: November 16, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–6851 Filed 4–1–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0184]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Temporary
Marketing Permit Applications
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
reporting requirements contained in
existing FDA regulations governing
temporary marketing permit
applications.
DATES: Submit written or electronic
comments on the collection of
information by June 2, 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:
Jonna Capezzuto,Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration,5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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.
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Sfmt 4703
‘‘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.
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
(OMB Control Number 0910–0133)—
Extension
Section 401 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
341) directs FDA to issue regulations
establishing definitions and standards of
identity for food ‘‘[w]henever * * *
such action will promote honesty and
fair dealing in the interest of consumers
* * * .’’ Under section 403(g) of the act
(21 U.S.C. 343(g)), a food that is subject
to a definition and standard of identity
prescribed by regulation is misbranded
if it does not conform to such definition
and standard of identity. Section 130.17
(21 CFR 130.17) provides for the
issuance by FDA of temporary
marketing permits that enable the food
industry to test consumer acceptance
and measure the technological and
commercial feasibility in interstate
commerce of experimental packs of food
that deviate from applicable definitions
and standards of identity. Section
130.17(c) enables the agency to monitor
the manufacture, labeling, and
distribution of experimental packs of
food that deviate from applicable
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Federal Register / Vol. 73, No. 64 / Wednesday, April 2, 2008 / Notices
definitions and standards of identity.
The information so obtained can be
used in support of a petition to establish
or amend the applicable definition or
standard of identity to provide for the
variations. Section 130.17(i) specifies
the information that a firm must submit
to FDA to obtain an extension of a
temporary marketing permit.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
130.17(c)
13
2
26
25
650
130.17(i)
1
2
2
2
4
Total
654
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on the agency’s experience with
applications received October 1, 2004,
through September 30, 2007, and
information from firms that have
submitted recent requests for temporary
marketing permits.
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 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6887 Filed 4–1–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0188]
Food Protection Plan; Outreach
Activities; Opportunity for Public
Comment
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC64 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that it is establishing a public docket to
receive information and comments
related to its comprehensive Food
Protection Plan (the Plan) released in
November 2007. The new Plan presents
a robust strategy to protect the nation’s
food supply from both unintentional
contamination and deliberate attack.
FDA is establishing this docket for the
purpose of soliciting comments from its
VerDate Aug<31>2005
15:36 Apr 01, 2008
Jkt 214001
stakeholders on the Plan and the
questions set forth in this notice.
DATES: Submit written or electronic
comments by July 31, 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. To ensure timelier
processing of comments, FDA is no
longer accepting comments submitted to
the agency by e-mail. All comments to
FDA on the Plan should be submitted
through the docket.
FOR FURTHER INFORMATION CONTACT: Kari
Barrett, Office of the Commissioner
(HF–60), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20852, 301–827–9831,
FAX: 301–827–2866.
SUPPLEMENTARY INFORMATION:
I. Background
For more than 100 years, FDA has
protected the health of Americans by
ensuring the safety of the food supply
(other than meat, poultry, and processed
egg products that are regulated by the
U.S. Department of Agriculture). Every
day across the country people eat out,
buy groceries, cook meals for their
families, and feed their pets. Americans
expect that all their food will be safe,
and FDA plays a critical role in making
sure this is true. Specifically, FDA is
responsible for the safety of 80 percent
of all food sold in the United States.
The U.S. food supply is one of the
safest in the world. Current trends in the
food industry promise better nutrition
and wider choices for consumers. At the
same time, new trends in demographics,
consumption, food production
technology, and business practices all
pose challenges for maintaining this safe
food supply. For example, consumers
today want the convenience of opening
a bag of salad that is already prepared.
In the past a single head of lettuce that
was contaminated may have resulted in
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Fmt 4703
Sfmt 4703
one family being ill. Now, a
contaminated head of lettuce may be
processed with many others and be
placed into bags of convenience salad
that many consumers can buy. These
bags of salad, if contaminated, could
result in hundreds of illnesses.
The supply of food consumed in the
United States is increasingly imported,
introducing a greater challenge for
improving the information FDA has
regarding conditions under which food
is produced in foreign countries. The
United States trades with over 150
countries and territories with products
coming into over 300 U.S. ports. Fifteen
percent of the food supply by volume in
the United States is imported. Sixty
percent of fresh fruits and vegetables are
imported. More than 75 percent of
seafood is imported. Although many
foreign countries have well developed
regulatory systems to ensure food safety,
others have systems that may not be
able to ensure food safety to the same
degree.
FDA also faces the challenge of
foodborne illnesses caused by known
hazards as well as new threats. In 1999,
the Centers for Disease Control and
Prevention estimated that there were
approximately 76 million cases per year
of illness from foodborne agents in the
United States, with 325,000
hospitalizations and 5,000 deaths.
Foodborne illnesses are caused by more
than 200 different foodborne pathogens
(agents that can cause illness) of which
we are aware. The variety of agents
associated with foodborne illness has
steadily grown over the last few
decades, and there is every probability
that this list will continue to increase.
In addition, the recent incident in
which vegetable protein products were
contaminated with melamine was a
deliberate act for economic gain.
Although this was not considered an act
of terrorism, it resulted in the sickness
and death of cats and dogs.
Another important challenge is
effective communication. FDA, States,
and industry receive food safety
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]]>Agencies
[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Notices]
[Pages 17986-17987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0184]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Temporary Marketing Permit Applications
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 reporting requirements
contained in existing FDA regulations governing temporary marketing
permit applications.
DATES: Submit written or electronic comments on the collection of
information by June 2, 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: Jonna Capezzuto,Office of the Chief
Information Officer (HFA-250), Food and Drug Administration,5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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.
Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i) (OMB
Control Number 0910-0133)--Extension
Section 401 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 341) directs FDA to issue regulations establishing
definitions and standards of identity for food ``[w]henever * * * such
action will promote honesty and fair dealing in the interest of
consumers * * * .'' Under section 403(g) of the act (21 U.S.C. 343(g)),
a food that is subject to a definition and standard of identity
prescribed by regulation is misbranded if it does not conform to such
definition and standard of identity. Section 130.17 (21 CFR 130.17)
provides for the issuance by FDA of temporary marketing permits that
enable the food industry to test consumer acceptance and measure the
technological and commercial feasibility in interstate commerce of
experimental packs of food that deviate from applicable definitions and
standards of identity. Section 130.17(c) enables the agency to monitor
the manufacture, labeling, and distribution of experimental packs of
food that deviate from applicable
[[Page 17987]]
definitions and standards of identity. The information so obtained can
be used in support of a petition to establish or amend the applicable
definition or standard of identity to provide for the variations.
Section 130.17(i) specifies the information that a firm must submit to
FDA to obtain an extension of a temporary marketing permit.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17(c) 13 2 26 25 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17(i) 1 2 2 2 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 654
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary marketing permit applications and
hours per response is an average based on the agency's experience with
applications received October 1, 2004, through September 30, 2007, and
information from firms that have submitted recent requests for
temporary marketing permits.
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 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6887 Filed 4-1-08; 8:45 am]
BILLING CODE 4160-01-S
