Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications, 76343-76344 [E6-21636]
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76343
Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices
PHASE 1.—FOCUS GROUP TESTING
Estimated
number of responses per
respondent
Estimated
number of
respondents
Type of respondents
Average
burden per response
(in hours)
Annual total
burden
requested
(in hours)
Rejected Screeners .........................................................................................
Accepted Screeners ........................................................................................
Parents .............................................................................................................
Teens ...............................................................................................................
152
48
32
16
1.0
1.0
1.0
1.0
1/60
5/60
2.0
2.0
2
4
64
32
Total ..........................................................................................................
........................
........................
........................
102
PHASE 2.—PRE- AND POST-INTERVENTION PILOT CITY SURVEY TESTING
[based on two cities]
Estimated
number of responses per
respondent
Estimated
number of
respondents
Type of respondents
Average
burden per
response
(in hours)
Estimated annual total burden hours
requested
Screeners .........................................................................................................
Parents .............................................................................................................
Teens ...............................................................................................................
1,777
600
200
2.0
2.0
2.0
1/60
15/60
15/60
59
300
100
Total ..........................................................................................................
........................
........................
........................
459
Dated: December 13, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–21719 Filed 12–19–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
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.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
BILLING CODE 4163–18–P
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[Docket No. 2006N–0237]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
AGENCY:
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0910–0523)—Extension
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 19,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
VerDate Aug<31>2005
20:03 Dec 19, 2006
Jkt 211001
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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
(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.
In the Federal Register of June 22,
2006 (71 FR 35916), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20DEN1.SGM
20DEN1
76344
Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of Respondents
Part 3
43
1There
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0202]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by January 19,
2007.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
ADDRESSES:
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.
sroberts on PROD1PC70 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: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21636 Filed 12–19–06; 8:45 am]
ACTION:
Annual Frequency per
Response
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:
VerDate Aug<31>2005
20:03 Dec 19, 2006
Jkt 211001
Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002—21 CFR 1.278 to
1.285 (OMB Control Number 0910–
0520)—Extension
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 381(m)), which
requires that FDA receive prior notice
for food, including food for animals,
that is imported or offered for import
into the United States. Sections 1.278 to
1.282 of FDA’s regulations (21 CFR
1.278 to 1.282) set forth the
requirements for submitting prior
notice; §§ 1.283(d) and 1.285(j) (21 CFR
1.283(d) and 1.285(j)) set forth the
procedure for requesting FDA review
after an article of food has been refused
admission under section 801(m)(1) of
the act or placed under hold under
section 801(l) of the act; and § 1.285(i)
(21 CFR 1.285(i)) sets forth the
procedure for post-hold submissions.
Advance notice of imported food allows
FDA, with the support of the Bureau of
Customs and Border Protection (CBP), to
target import inspections more
effectively and help protect the nation’s
food supply against terrorist acts and
other public health emergencies.
Any person with knowledge of the
required information may submit prior
notice for an article of food. Thus, the
respondents to this information
collection may include importers,
owners, ultimate consignees, shippers,
and carriers.
FDA’s regulations require that prior
notice of imported food be submitted
electronically using CBP’s Automated
Broker Interface of the Automated
Commercial System (ABI/ACS)
(§ 1.280(a)(1)) or the FDA Prior Notice
(PN) System Interface (Form FDA 3540)
(§ 1.280(a)(2)). The term ‘‘Form FDA
3540’’ refers to the electronic system
known as the FDA PN System Interface,
which is available at https://
www.access.fda.gov. Prior notice must
be submitted electronically using either
ABI/ACS or the FDA PN System
Interface. Information collected by FDA
in the prior notice submission includes:
The submitter and transmitter (if
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
different from the submitter); entry type
and CBP identifier; the article of food,
including complete FDA product code;
the manufacturer, for an article of food
no longer in its natural state; the grower,
if known, for an article of food that is
in its natural state; the FDA Country of
Production; the shipper, except for food
imported by international mail; the
country from which the article of food
is shipped or, if the food is imported by
international mail, the anticipated date
of mailing and country from which the
food is mailed; the anticipated arrival
information or, if the food is imported
by international mail, the U.S. recipient;
the importer, owner, and ultimate
consignee, except for food imported by
international mail or transshipped
through the United States; the carrier
and mode of transportation, except for
food imported by international mail;
and planned shipment information,
except for food imported by
international mail (§ 1.281).
Much of the information collected for
prior notice is identical to the
information collected for FDA’s
importer’s entry notice, which has been
approved under OMB control number
0910–0046. The information in FDA’s
importer’s entry notice is collected
electronically via CBP’s ABI/ACS at the
same time the respondent files an entry
for import with CBP. To avoid doublecounting the burden hours already
counted in the importer’s entry notice
information collection, the burden hour
analysis in table 1 of this document
reflects the reduced burden for prior
notice submitted through ABI/ACS in
the column labeled ‘‘Hours per
Response.’’
In addition to submitting a prior
notice, a submitter should cancel a prior
notice and must resubmit the
information if information changes after
FDA has confirmed a prior notice
submission for review (e.g., if the
identity of the manufacturer changes)
(§ 1.282). However, changes in the
estimated quantity, anticipated arrival
information, or planned shipment
information do not require resubmission
of prior notice after FDA has confirmed
a prior notice submission for review
(§ 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the
event that an article of food has been
refused admission under section
801(m)(1) of the act or placed under
E:\FR\FM\20DEN1.SGM
20DEN1
]]>Agencies
[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76343-76344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21636]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0237]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
19, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Product Jurisdiction: Assignment of Agency Component for Review of
Premarket Applications--(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.
In the Federal Register of June 22, 2006 (71 FR 35916), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 76344]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
21 CFR Section No. of Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21636 Filed 12-19-06; 8:45 am]
BILLING CODE 4160-01-S
