Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 35916-35917 [E6-9900]
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35916
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
FR 18105), 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 0910–0571. The
approval expires on May 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
OMB control number 0910–0583. The
approval expires on April 30, 2009. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9826 Filed 6–21–06; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: June 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9824 Filed 6–21–06; 8:45 am]
[Docket No. 2005N–0457]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Substances Generally Recognized as
Safe: Notification Procedure
Food and Drug Administration
AGENCY:
BILLING CODE 4160–01–S
[Docket No. 2004D–0369]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Recommendations for Early Food
Safety Evaluation of New NonPesticidal Proteins Produced by New
Plant Varieties Intended for Food Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Recommendations for Early Food
Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 10, 2006
(71 FR 7048), 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
wwhite on PROD1PC61 with NOTICES
SUMMARY:
19:08 Jun 21, 2006
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Substances Generally Recognized as
Safe: Notification Procedure’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Notice.
VerDate Aug<31>2005
Food and Drug Administration,
HHS.
Jkt 208001
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
In the
Federal Register of April 7, 2006 (67 FR
17892), 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 0910–0342. The
approval expires on May 31, 2009. 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: June 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9827 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. 2006N–0237]
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 procedure by which an applicant
may obtain an assignment or
designation determination.
DATES: Submit written or electronic
comments on the collection of
information by August 21, 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:
Jonna Capezzuto, Office of Management
Programs (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
E:\FR\FM\22JNN1.SGM
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35917
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
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.
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—21 CFR Part 3
(OMB Control Number 0910–0523)—
Extension
This regulation relates to agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Public Law 101–629), and
amended by the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250), by specifying
how FDA will determine the
organizational component within FDA
assigned to have primary jurisdiction for
the premarket review and regulation of
products that are comprised of any of
the following combinations: (1) A drug
and a device; (2) a device and a
biological; (3) a biological and a drug; or
(4) a drug, a device, and a biological.
The second purpose of this regulation is
to enhance the efficiency of agency
management and operations by
providing procedures for classifying and
determining which agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biologicals, and
combination products. The respondents
will be businesses or other for-profit
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Part 3
1There
43
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006O–0232]
Over-the-Counter Drug Products;
Safety and Efficacy Review; Additional
Laxative Ingredient
Food and Drug Administration,
HHS.
Notice of eligibility; request for
data and information.
ACTION:
wwhite on PROD1PC61 with NOTICES
Total Annual
Responses
1
Hours per Response
43
24
Total Hours
1,032
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–9900 Filed 6–21–06; 8:45 am]
AGENCY:
Annual Frequency per
Response
No. of Respondents
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
call-for-data for safety and effectiveness
information on the following condition
as part of FDA’s ongoing review of overthe-counter (OTC) drug products:
Sodium picosulfate, up to 10 milligrams
VerDate Aug<31>2005
19:08 Jun 21, 2006
Jkt 208001
(mg), as a laxative single active
ingredient. FDA reviewed a time and
extent application (TEA) for this
condition and determined that it is
eligible for consideration in our OTC
drug monograph system. FDA will
evaluate the submitted data and
information to determine whether this
condition can be generally recognized as
safe and effective (GRAS/E) for its
proposed OTC use.
DATES: Submit data, information, and
comments by September 20, 2006.
ADDRESSES: Submit comments, data,
and information to the Division of
Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments, data, and
information to https://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Michael L. Koenig, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., WO Bldg. 22, Mail
Stop 5411, Silver Spring, MD 20993,
301–796–2090.
SUPPLEMENTARY INFORMATION:
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I. Background
In the Federal Register of January 23,
2002 (67 FR 3060), FDA published a
final rule establishing criteria and
procedures for additional conditions to
become eligible for consideration in the
OTC drug monograph system. These
criteria and procedures, codified in
§ 330.14 (21 CFR 330.14), permit OTC
drugs initially marketed in the United
States after the OTC drug review began
in 1972 and OTC drugs without any
marketing experience in the United
States to become eligible for FDA’s OTC
drug monograph system. The term
‘‘condition’’ means an active ingredient
or botanical drug substance (or a
combination of active ingredients or
botanical drug substances), dosage form,
dosage strength, or route of
administration, marketed for a specific
OTC use (§ 330.14 (a)). The criteria and
procedures also permit conditions that
are regulated as cosmetics or dietary
supplements in foreign countries but
that would be regulated as OTC drugs in
the United States to become eligible for
the OTC drug monograph system.
E:\FR\FM\22JNN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35916-35917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9900]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0237]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Product Jurisdiction: Assignment of Agency Component
for Review of Premarket 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 the procedure by which an
applicant may obtain an assignment or designation determination.
DATES: Submit written or electronic comments on the collection of
information by August 21, 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: Jonna Capezzuto, Office of Management
Programs (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
[[Page 35917]]
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.
Product Jurisdiction: Assignment of Agency Component for Review of
Premarket Applications--21 CFR Part 3 (OMB Control Number 0910-0523)--
Extension
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by
the Safe Medical Devices Act of 1990 (Public Law 101-629), and amended
by the Medical Device User Fee and Modernization Act of 2002 (Public
Law 107-250), by specifying how FDA will determine the organizational
component within FDA assigned to have primary jurisdiction for the
premarket review and regulation of products that are comprised of any
of the following combinations: (1) A drug and a device; (2) a device
and a biological; (3) a biological and a drug; or (4) a drug, a device,
and a biological. The second purpose of this regulation is to enhance
the efficiency of agency management and operations by providing
procedures for classifying and determining which agency component is
designated to have primary jurisdiction for any drug, device, or
biological product where such jurisdiction is unclear or in dispute.
The regulation establishes a procedure by which an applicant may
obtain an assignment or designation determination. The regulation
requires that the request include the identity of the applicant, a
comprehensive description of the product and its proposed use, and the
applicant's recommendation as to which agency component should have
primary jurisdiction, with an accompanying statement of reasons. The
information submitted would be used by FDA as the basis for making the
assignment or designation decision. Most information required by the
regulation is already required for premarket applications affecting
drugs, devices, biologicals, and combination products. The respondents
will be businesses or other for-profit organizations.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR No. of Respondents Frequency per Total Annual Hours per Response Total Hours
Response Responses
----------------------------------------------------------------------------------------------------------------
Part 3 43 1 43 24 1,032
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9900 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S
