Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date, 78371 [E8-30297]

Download as PDF 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] mstockstill on PROD1PC66 with NOTICES BILLING CODE 4184–01–M VerDate Aug<31>2005 19:07 Dec 19, 2008 Jkt 217001 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] BILLING CODE 4160–01–S E:\FR\FM\22DEN1.SGM 22DEN1

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]


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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.

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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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