Notice of Availability of Draft Policy Documents for Comment, 58106 [E7-20171]
Download as PDF
<![CDATA[
58106
Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices
VI. Implementation of Adjusted Fee
Schedule
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Application Fees
Food and Drug Administration
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received after September
30, 2007. Payment must be made in U.S.
currency by check, bank draft, or U.S.
postal money order payable to the order
of the Food and Drug Administration.
Please include the user fee ID number
on your check. Your payment can be
mailed to: Food and Drug
Administration, P.O. Box 70963,
Charlotte, NC 28272–0963.
If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to:
Wachovia Bank, Attn: Food and Drug
Administration Lockbox 70963, 1525
West WT Harris Blvd., rm. NC0810,
Charlotte, NC 28262. (Note: This
Wachovia Bank address is for courier
delivery only.)
Please make sure that the FDA post
office box number (P.O. Box 70963) is
written on the check. The tax
identification number of the Food and
Drug Administration is 53–0196965.
Wire transfer payment may also be
used. The routing and transit number is
021030004 and the account number is
75060099. Please include, as the
reference, the NDA/BLA number and
the user fee ID number.
FDA is in the process of
implementing alternate Web-based
payment methods. For more information
on these payment options and when
they will be available, please visit FDA’s
Web site at https://www.fda.gov, select
the appropriate user fee type, and click
on ‘‘User Fee Cover Sheet.’’
[Docket No. 2007D–0309]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Electrocardiograph Electrodes;
Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 4, 2007 (72 FR
56771). The document announced the
availability of a draft guidance entitled
‘‘Class II Special Controls Guidance
Document: Electrocardiograph
Electrodes.’’ The document was
published with an incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy (HF–
27), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–7010.
In FR Doc.
E7–19578, appearing on page 56771 in
the Federal Register of Thursday,
October 4, 2007, the following
correction is made:
1. On page 56771, in the third
column, in the heading of the
document, ‘‘[Docket No. 2007N–0309]’’
is corrected to read ‘‘[Docket No.
2007D–0309]’’.
SUPPLEMENTARY INFORMATION:
Dated: October 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20183 Filed 10–11–07; 8:45 am]
BILLING CODE 4160–01–S
B. Establishment and Product Fees
jlentini on PROD1PC65 with NOTICES
FDA will issue invoices for
establishment and product fees for FY
2008 under the new fee schedule in
October 2007. Payment will be due 30
days from the date of the invoice. FDA
will issue invoices in November 2008
for any products and establishments
subject to fees for FY 2008 that qualify
for fees after the October 2007 billing.
Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07–5052 Filed 10–9–07; 12:06 pm]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:35 Oct 11, 2007
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Draft Policy
Documents for Comment
Health Resources and Services
Administration, HHS.
ACTION: Extension of requests for
comments deadline.
AGENCY:
SUMMARY: The Health Resources and
Services Administration published a
notice in the Federal Register of August
29, 2007, requesting comments on draft
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Agency Guidance (Policy Information
Notices (PINS)) to describe the policy
and processes pertaining to requests
from federally-funded health centers to
change the scope of their Federal
project. The PINS, ‘‘Defining Scope of
Project and Policy for Requesting
Changes,’’ ‘‘Changes in Scope Requests:
Policy for Adding a New Target
Population,’’ and ‘‘Specialty Services
and Health Centers’ Scope of Project,’’
are available on the Internet at https://
bphc.hrsa.gov.
Correction: In the Federal Register of
August 29, 2007, FR Doc. E7–17092, on
page 49724, in the first column, under
DATES, the deadline for comments has
been extended to October 19, 2007.
Dated: October 5, 2007.
Dennis P. Williams,
Deputy Administrator.
[FR Doc. E7–20171 Filed 10–11–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 72, Number 197 (Friday, October 12, 2007)]
[Notices]
[Page 58106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20171]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Availability of Draft Policy Documents for Comment
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Extension of requests for comments deadline.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration published a
notice in the Federal Register of August 29, 2007, requesting comments
on draft Agency Guidance (Policy Information Notices (PINS)) to
describe the policy and processes pertaining to requests from
federally-funded health centers to change the scope of their Federal
project. The PINS, ``Defining Scope of Project and Policy for
Requesting Changes,'' ``Changes in Scope Requests: Policy for Adding a
New Target Population,'' and ``Specialty Services and Health Centers'
Scope of Project,'' are available on the Internet at https://
bphc.hrsa.gov.
Correction: In the Federal Register of August 29, 2007, FR Doc. E7-
17092, on page 49724, in the first column, under DATES, the deadline
for comments has been extended to October 19, 2007.
Dated: October 5, 2007.
Dennis P. Williams,
Deputy Administrator.
[FR Doc. E7-20171 Filed 10-11-07; 8:45 am]
BILLING CODE 4165-15-P
