Statement of Delegation of Authority, 8550 [E9-3838]
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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
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Fmt 4703
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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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[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Page 8550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3838]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
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 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 4165-15-M
