Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date, 78371 [E8-30297]
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78371
Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices
couples and families that have
implications for the design and delivery
of healthy marriage education services
to Hispanics, recognizing their diversity
with respect to country of origin,
language, and level of acculturation,
among other factors.
groups with Hispanic individuals and
couples participating in selected
marriage education programs or
declining to participate in such
programs. Through this information
collection and other study activities,
ACF and ASPE seek to identify the
unique cultural needs of Hispanic
Respondents: Marriage education
program directors and managers; staff
responsible for outreach, recruitment
and intake activities in marriage
education programs; marriage education
instructors; and key persons in partner
organizations.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Program Staff Discussion Guide .....................................................................
Partners/Community Leaders Discussion Guide .............................................
Participant Focus Group Discussion Guide .....................................................
81
54
180
1
1
1
2
2
1
162
108
180
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
450
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: December 11, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8–30172 Filed 12–19–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0298] (formerly
Docket No. 2004D–0499)
Compliance Policy Guide;
Radiofrequency Identification
Feasibility Studies and Pilot Programs
for Drugs; Notice to Extend Expiration
Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of expiration
date.
SUMMARY: The Food and Drug
Administration (FDA) is extending the
expiration date of compliance policy
guide (CPG) Sec. 400.210 entitled
‘‘Radiofrequency Identification (RFID)
Feasibility Studies and Pilot Programs
for Drugs’’ to December 31, 2010.
FOR FURTHER INFORMATION CONTACT: Ilisa
Bernstein, Office of the Commissioner,
Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4341, Silver Spring,
MD 20993–0002, 301–796–4830.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 17, 2004
(69 FR 67360), FDA announced the
availability of CPG Sec. 400.210 entitled
‘‘Radiofrequency Identification (RFID)
Feasibility Studies and Pilot Programs
for Drugs.’’ FDA has identified RFID as
a promising technology to be used in the
various efforts to combat counterfeit
drugs. The CPG describes how the
agency intends to exercise its
enforcement discretion regarding certain
regulatory requirements that might
otherwise be applicable to studies
involving RFID technology for drugs.
The goal of the CPG is to facilitate
performance of RFID studies and to
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
allow industry to gain experience with
the use of RFID technology and its effect
on the long-term safety and integrity of
the U.S. drug supply.
On September 27, 2007, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) was signed into law.
Section 913 of FDAAA addresses
pharmaceutical safety and creates
section 505D of the Federal Food, Drug,
and Cosmetic Act (the act). Section
505D(b) of the act requires the
development of standards for the
identification, validation,
authentication, and tracking and tracing
of prescription drugs. Section
505D(b)(3) of the act states that these
new standards shall address promising
technologies, which may include RFID
technology.
In implementing section 505D of the
act, FDA is currently addressing issues,
such as promising technologies, that are
relevant also for the CPG. In addition,
FDA is considering further the
experience of stakeholders and the
agency under the CPG. As we consider
all of these issues, the CPG will remain
in effect until December 31, 2010.
Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30297 Filed 12–19–08; 8:45 am]
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Agencies
[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Page 78371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30297]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-D-0298] (formerly Docket No. 2004D-0499)
Compliance Policy Guide; Radiofrequency Identification
Feasibility Studies and Pilot Programs for Drugs; Notice to Extend
Expiration Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of expiration date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
expiration date of compliance policy guide (CPG) Sec. 400.210 entitled
``Radiofrequency Identification (RFID) Feasibility Studies and Pilot
Programs for Drugs'' to December 31, 2010.
FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of the
Commissioner, Office of Policy, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4341, Silver Spring, MD 20993-0002, 301-
796-4830.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2004
(69 FR 67360), FDA announced the availability of CPG Sec. 400.210
entitled ``Radiofrequency Identification (RFID) Feasibility Studies and
Pilot Programs for Drugs.'' FDA has identified RFID as a promising
technology to be used in the various efforts to combat counterfeit
drugs. The CPG describes how the agency intends to exercise its
enforcement discretion regarding certain regulatory requirements that
might otherwise be applicable to studies involving RFID technology for
drugs. The goal of the CPG is to facilitate performance of RFID studies
and to allow industry to gain experience with the use of RFID
technology and its effect on the long-term safety and integrity of the
U.S. drug supply.
On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA) was signed into law. Section 913 of FDAAA addresses
pharmaceutical safety and creates section 505D of the Federal Food,
Drug, and Cosmetic Act (the act). Section 505D(b) of the act requires
the development of standards for the identification, validation,
authentication, and tracking and tracing of prescription drugs. Section
505D(b)(3) of the act states that these new standards shall address
promising technologies, which may include RFID technology.
In implementing section 505D of the act, FDA is currently
addressing issues, such as promising technologies, that are relevant
also for the CPG. In addition, FDA is considering further the
experience of stakeholders and the agency under the CPG. As we consider
all of these issues, the CPG will remain in effect until December 31,
2010.
Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30297 Filed 12-19-08; 8:45 am]
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