Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice, 8549-8550 [E9-3938]
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Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
Part 803 requires user facilities to
report to the device manufacturer and to
FDA in case of a death, incidents where
a medical device caused or contributed
to a death or serious injury.
Additionally, user facilities are required
to annually submit the number and
summary of advents reported during the
calendar year, using FDA Form 3419.
Manufacturers of medical devices are
required to report to FDA when they
become aware of information indicating
that one of their devices may have
caused or contributed to death or
serious injury or has malfunctioned in
such a way that should the malfunction
recur it would be likely to cause or
contribute to a death or serious injury.
Device importers report deaths and
serious injuries to the manufacturers
and FDA. Importers report malfunctions
only to the manufacturers, unless they
are unknown, then the reports are sent
to FDA.
The number of respondents for each
CFR section in table 1 of this document
is based upon the number of
respondents entered into FDA’s internal
databases. FDA estimates, based on its
experience and interaction with the
medical device community, that all
reporting CFR sections are expected to
take 1 hour to complete, with the
exception of § 803.19. Section 803.19 is
expected to take approximately 3 hours
to complete, but is only required for
reporting the summarized data quarterly
to FDA. By summarizing events, the
total time used to report for this section
is reduced because the respondents do
not submit a full report for each event
they report in a quarterly summary
report.
The agency believes that the majority
of manufacturers, user facilities, and
importers have already established
written procedures to document
complaints and information to meet the
MDR requirements as part of their
internal quality control system. There
are an estimated 30,000 medical device
distributors. Although they do not
submit MDR reports, they must
maintain records of complaints, under
§ 803.18(d).
The agency has estimated that on
average 220 user facilities, importers,
and manufacturers would annually be
required to establish new procedures, or
revise existing procedures, in order to
comply with this provision.
Therefore, FDA estimates the onetime burden to respondents for
establishing or revising procedures
under § 803.17 to be 2,200 hours (220
respondents x 10 hours). For those
entities, a one-time burden of 10 hours
is estimated for establishing written
MDR procedures. The remaining
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18:09 Feb 24, 2009
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manufacturers, user facilities, and
importers, not required to revise their
written procedures to comply with this
provision, are excluded from the burden
because the recordkeeping activities
needed to comply with this provision
are considered ‘‘usual and customary’’
under 5 CFR 1320.3(b)(2).
Under § 803.18, 30,000 respondents
represent distributors, importers, and
other respondents to this information
collection. FDA estimates that it should
take them approximately 1.5 hours to
complete the recordkeeping requirement
for this section. Total hours for this
section equal 45,000 hours.
Dated: February 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4057 Filed 2–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Importer’s Entry
Notice
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
FDA’s need to collect additional
information in the Importer’s Entry
Notice.
DATES: Submit written or electronic
comments on the collection of
information by April 27, 2009.
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
8549
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth G. Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Importer’s Entry Notice (OMB Control
Number 0910–0046–Extension)
In order to make an admissibility
decision for each entry, FDA needs four
additional pieces of information that are
not available in the U.S. Customs and
Border Protection’s (CBP’s) data set.
These data elements are the FDA
Product Code, FDA country of
production, FDA manufacturer/shipper,
and ultimate consignee. It is the
‘‘automated’’ collection of these four
data elements for which OMB approval
is requested. FDA construes this request
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8550
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
products. FDA may authorize specific
lines to enter the U.S. unimpeded, while
others in the same entry are to be held
pending further FDA review/action.
An important feature developed and
programmed into FDA’s automated
system is that all entry data passes
through a screening criteria program.
FDA’s electronic screening criteria
module makes the initial screening
decision on every entry of foreign-origin
FDA-regulated product. Virtually
instantaneously after the entry is filed,
the filer receives FDA’s admissibility
decision covering each entry, i.e., ‘‘MAY
PROCEED’’ or ‘‘FDA REVIEW.’’
Examples of FDA’s need to further
review an entry include: Products
originating from a specific country or
manufacturer known to have a history of
problems, FDA has no previous
knowledge of the foreign manufacturer
and/or product, and an import alert
covering the product has been issued,
etc. The system assists FDA entry
reviewers by notifying them of
as an extension of the prior approval of
collection of this data via a different
media, i.e., paper. There are additional
data elements that filers can provide to
FDA along with other entry-related
information that, by doing so, may
result in their receiving an FDA
admissibility decision more
expeditiously, e.g., the quantity, value,
and Affirmation(s) of Compliance with
Qualifier(s).
At each U.S. port of entry (seaport,
landport, and airport) where foreignorigin FDA-regulated products are
offered for import, FDA is notified
through CBP’s Automated Commercial
System (ACS) by the importer (or his
agent) of the arrival of each entry.
Following such notification FDA
reviews relevant data to ensure the
imported product meets the standards
as are required for domestic products,
makes an admissibility decision, and
informs the importer and CBP of its
decision. A single entry frequently
contains multiple lines of different
information such as the issuance of
import alerts, thus averting the chance
that such information will be missed.
With the inception of the interface
with CBP’s ACS, FDA’s electronic
screening criteria program is applied
nationwide. This virtually eliminates
problems such as ‘‘port shopping,’’ e.g.,
attempts to intentionally slip products
through one FDA port when refused by
another, or to file entries at a port
known to receive a high volume of
entries. Every electronically submitted
entry line of foreign-origin FDAregulated product undergoes automated
screening described previously in this
document. The screening criteria can be
set to be as specific or as broad as
applicable; changes are virtually
immediately effective. This capability is
of tremendous value in protecting the
public in the event there is a need to
immediately halt a specific product
from entering the United States.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency per
Response
No. of Respondents
3,727
1 There
1,070
Hours per
Response
3,988,371
Total Hours
.263
1,048,447
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–3938 Filed 2–24–09; 8:45 am]
authorities prior to the effective date of
this delegation.
This delegation is effective upon date
of signature.
Dated: February 9, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9–3838 Filed 2–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4165–15–M
Statement of Delegation of Authority
Notice is hereby given that I have
delegated to the Administrator, Health
Resources and Services Administration
certain authorities vested in the
Secretary, Health and Human Services
(HRSA) under Section 307(C), Title III of
the Denali Commission Act of 1998, as
amended hereafter, pertaining to the
Denali Commission’s Demonstration
Health Projects.
This delegation shall be exercised in
accordance with the Department’s
applicable policies, procedures and
guidelines relating to regulations.
In addition, I have affirmed and
ratified any actions taken by the HRSA
Administrator, or other HRSA officials,
which involved the exercise of these
VerDate Nov<24>2008
18:09 Feb 24, 2009
Jkt 217001
Department’s applicable policies,
procedures, and guidelines.
In addition, I have affirmed and
ratified any actions taken by the
Administrator, or other HRSA officials,
which involved the exercise of these
authorities prior to the effective date of
this delegation.
This delegation is effective upon date
of signature.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
pwalker on PROD1PC71 with NOTICES
Total Annual
Responses
Dated: February 9, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9–3842 Filed 2–24–09; 8:45 am]
Health Resources and Services
Administration
BILLING CODE 4165–15–M
Statement of Delegation of Authority
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice is hereby given that I have
delegated to the Administrator, Health
Resources and Services Administration,
certain authorities vested in the
Secretary of Health and Human Services
under Section 219 of Public Law 110–
161, as amended hereafter, pertaining to
the Delta Health Initiative.
These authorities may be redelegated.
This delegation excludes the authority
to issue regulations and to submit
reports to Congress, and shall be
exercised in accordance with the
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Indian Health Service
Indian Health Professions Preparatory,
Indian Health Professions Pregraduate
and Indian Health Professions
Scholarship Programs
Announcement Type: Initial.
CFDA Numbers: 93.971, 93.123, and
93.972.
Key Dates:
Application Deadline: February 28,
2009, for Continuing students.
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]]>Agencies
[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8549-8550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3938]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Importer's Entry Notice
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 FDA's need to collect
additional information in the Importer's Entry Notice.
DATES: Submit written or electronic comments on the collection of
information by April 27, 2009.
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: Elizabeth G. Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Importer's Entry Notice (OMB Control Number 0910-0046-Extension)
In order to make an admissibility decision for each entry, FDA
needs four additional pieces of information that are not available in
the U.S. Customs and Border Protection's (CBP's) data set. These data
elements are the FDA Product Code, FDA country of production, FDA
manufacturer/shipper, and ultimate consignee. It is the ``automated''
collection of these four data elements for which OMB approval is
requested. FDA construes this request
[[Page 8550]]
as an extension of the prior approval of collection of this data via a
different media, i.e., paper. There are additional data elements that
filers can provide to FDA along with other entry-related information
that, by doing so, may result in their receiving an FDA admissibility
decision more expeditiously, e.g., the quantity, value, and
Affirmation(s) of Compliance with Qualifier(s).
At each U.S. port of entry (seaport, landport, and airport) where
foreign-origin FDA-regulated products are offered for import, FDA is
notified through CBP's Automated Commercial System (ACS) by the
importer (or his agent) of the arrival of each entry. Following such
notification FDA reviews relevant data to ensure the imported product
meets the standards as are required for domestic products, makes an
admissibility decision, and informs the importer and CBP of its
decision. A single entry frequently contains multiple lines of
different products. FDA may authorize specific lines to enter the U.S.
unimpeded, while others in the same entry are to be held pending
further FDA review/action.
An important feature developed and programmed into FDA's automated
system is that all entry data passes through a screening criteria
program. FDA's electronic screening criteria module makes the initial
screening decision on every entry of foreign-origin FDA-regulated
product. Virtually instantaneously after the entry is filed, the filer
receives FDA's admissibility decision covering each entry, i.e., ``MAY
PROCEED'' or ``FDA REVIEW.''
Examples of FDA's need to further review an entry include: Products
originating from a specific country or manufacturer known to have a
history of problems, FDA has no previous knowledge of the foreign
manufacturer and/or product, and an import alert covering the product
has been issued, etc. The system assists FDA entry reviewers by
notifying them of information such as the issuance of import alerts,
thus averting the chance that such information will be missed.
With the inception of the interface with CBP's ACS, FDA's
electronic screening criteria program is applied nationwide. This
virtually eliminates problems such as ``port shopping,'' e.g., attempts
to intentionally slip products through one FDA port when refused by
another, or to file entries at a port known to receive a high volume of
entries. Every electronically submitted entry line of foreign-origin
FDA-regulated product undergoes automated screening described
previously in this document. The screening criteria can be set to be as
specific or as broad as applicable; changes are virtually immediately
effective. This capability is of tremendous value in protecting the
public in the event there is a need to immediately halt a specific
product from entering the United States.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,727 1,070 3,988,371 .263 1,048,447
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3938 Filed 2-24-09; 8:45 am]
BILLING CODE 4160-01-S
