Gastrointestinal Drugs Advisory Committee; Cancellation, 27072 [2012-10990]

Download as PDF 27072 Federal Register / Vol. 77, No. 89 / Tuesday, May 8, 2012 / Notices subsequent 60 day notices for later components of the evaluation. The first phase includes data collection for a cross-site implementation study and site-specific impact evaluations in two PIT grantee sites (Kansas; Washoe County, Nevada) that will begin implementing interventions during the second year of the PII grant period. The second phase includes a cross-site cost evaluation and site-specific impact evaluations in four PII grantee sites expected to implement interventions in the third year of the PII grant period. Data for the cross-site implementation study will be collected through: (1) Interviews with grantee staff and key informants conducted by telephone and during site visits; (2) web-based instruments completed by grantee staff and key informants; and (3) retrieval and submission of aggregate data from grantee data systems. Data for the Kansas impact evaluation will be collected through (1) family assessments; (2) caseworkers’ clinical assessments of children and families; and (3) caseworker discussions. Data for the Washoe County impact evaluation will be collected through family assessments. Respondents: Families (parents, or permanent or foster caregivers; children), caseworkers, supervisors, service providers, and key informants such as grantee project directors, data managers, and representatives of partner agencies. ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument Number of responses per respondent 60 150 30 2 — 1 2 4 8 — 0.3 0.8 2.0 1.5 — 18 240 240 24 522 300 300 4 4 — 1 3 150 150 — 0.1 1.5 1.0 0.5 — 30 1350 600 300 2280 175 — 2 — 1.5 — 525 525 srobinson on DSK4SPTVN1PROD with NOTICES CROSS-SITE IMPLEMENTATION STUDY: Survey of Organization/System Readiness ..................................................... Implementation Drivers Web Survey ............................................................... Grantee Case Study Protocol .......................................................................... Fidelity Data (Implementation Quotient Tracker) ............................................. Cross-Site Estimated Total .............................................................................. KANSAS: Caregiver Initial Information Form ............................................................ Family Assessment Battery ...................................................................... CAFAS/PECFAS ...................................................................................... Caseworker Discussions for NCFAS–G&R Completion .................................. Kansas Estimated Total ................................................................................... WASHOE COUNTY: Family Assessment Battery ...................................................................... Washoe Estimated Total .......................................................................... Estimated Total Annual Burden Hours: 3327. 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. Email 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, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the VerDate Mar<15>2010 17:33 May 07, 2012 Jkt 226001 Administration, for Children and Families. Steven M. Hanmer, OPRE Reports Clearance Officer. [FR Doc. 2012–10848 Filed 5–7–12; 8:45 am] BILLING CODE 4184–01–M Average burden hours per response Total annual burden hours information which negated the necessity for the planned meeting. The Agency intends to continue evaluating NDA 200–436 and, as needed, may schedule an Advisory Committee meeting in the future. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Gastrointestinal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is canceled. This meeting was announced in the Federal Register of March 23, 2012 (77 FR 17078). The meeting is being canceled because the Agency no longer needs to discuss the issues that were originally under consideration in the review of the application. The sponsor of the new drug application (NDA) submitted new SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301–847–8533, email: GIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information or visit our Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: May 2, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–10990 Filed 5–7–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 77, Number 89 (Tuesday, May 8, 2012)]
[Notices]
[Page 27072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Gastrointestinal Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Gastrointestinal Drugs Advisory Committee 
scheduled for May 31, 2012, is canceled. This meeting was announced in 
the Federal Register of March 23, 2012 (77 FR 17078). The meeting is 
being canceled because the Agency no longer needs to discuss the issues 
that were originally under consideration in the review of the 
application. The sponsor of the new drug application (NDA) submitted 
new information which negated the necessity for the planned meeting. 
The Agency intends to continue evaluating NDA 200-436 and, as needed, 
may schedule an Advisory Committee meeting in the future.

FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 
301-847-8533, email: GIDAC@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), to find out further information regarding FDA advisory committee 
information or visit our Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 2, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-10990 Filed 5-7-12; 8:45 am]
BILLING CODE 4160-01-P
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