Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 36331-36332 [E8-14515]

Download as PDF 36331 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices Estimated Total Annual Burden Hours: 125 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@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: June 18, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–14161 Filed 6–25–08; 8:45 am] BILLING CODE 4184–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Office of Refugee Resettlement; Unaccompanied Alien Children Shelter Care Facilities Office of Refugee Resettlement, ACF, DHHS. AGENCY: Notice to award ten noncompetitive supplements to existing Unaccompanied Alien Children (UAC) Shelter Care Facilities. ACTION: CFDA #: 93.676. Legslative Authority: The Office of Refugee Resettlement (ORR) is mandated by Section 462 of the Homeland Security Act to ensure appropriate placement of all unaccompanied alien children referred to ORR for care and custody by the Department of Homeland Security (DHS). Amount of Award: $2,521,320. SUMMARY: This notice announces that the Administration for Children and Families (ACF), Office of Refugee Resettlement intends to award ten unaccompanied alien shelter care providers in the amount of $2,521,320. This funding will support services through September 30, 2008. Location Southwest Key—El Paso .............................. The Children’s Village ................................... Florence Crittenton ....................................... Lutheran Social Services of the South ......... Heartland/ICC ............................................... Southwest Indiana Youth Village .................. International Educational Services—Foster Care. International Educational Services—Foster Care. Pioneer Services ........................................... Southwest Key—Pleasant Hill ...................... rfrederick on PROD1PC67 with NOTICES Grantee El Paso, TX .................................................. New York, NY ............................................... Los Angeles, CA .......................................... Austin, TX ..................................................... Chicago, IL ................................................... Vincennes, IN ............................................... Brownsville, TX ............................................. 06/10/08–09/30/08 06/10/08–09/30/08 06/10/08–09/30/08 06/10/08–09/30/08 06/10/08–09/30/08 06/10/08–09/30/08 06/10/08–09/30/08 $390,320 445,000 336,000 600,000 325,000 120,000 90,000 Harlingen, TX ............................................... 06/10/08–09/30/08 70,000 Fife, WA ........................................................ Pleasant Hill, CA .......................................... 06/10/08–09/30/08 06/10/08–09/30/08 85,000 60,000 This funding will support the expansion of shelter/foster/staff secure/ secured/therapeutic care program bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). This expansion is necessary to replace bed capacity discontinued at several sites as well as to accommodate the increase of length of stay of UAC in ORR’s care. This supplemental funding will support the additional bed capacity through the summer high season, terminating at the end of the 2008 fiscal year. To ensure the program would have complete flexibility to expand and contract to meet the ever-changing demands of the program, ORR specifically included language in its program announcement to stipulate that funding and capacity may increase based on the needs of the program. The program has very specific requirements for the provision of services. Existing grantees are the only entities with the infrastructure, licensing, experience and appropriate level of trained staff to meet VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 Project period the service requirements and the urgent need for expansion. The program’s ability to avoid a backlog of children waiting in border patrol stations for placement can only be accommodated through the expansion of existing programs through this supplemental award process. FOR FURTHER INFORMATION CONTACT: Kenneth Tota, Office of Refugee Resettlement, Administration for Children and Families, 370 L’Enfant Promenade, SW., Washington, DC 20447, telephone (202) 401–4858. Dated: June 17, 2008. David H. Siegel, Acting Director, Office of Refugee Resettlement. [FR Doc. E8–14429 Filed 6–25–08; 8:45 am] BILLING CODE 4184–01–P PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Amount DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0173] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 28, 2008. E:\FR\FM\26JNN1.SGM 26JNN1 36332 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0566. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: collection of information to OMB for review and clearance. Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine (OMB Control Number 0910–0566)—Extension CVM’s (Center for Veterinary Medicine) ‘‘Guidance for Industry #79— Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ describes the process by which CVM formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training or experience to be understood and resolved. Further, the guidance details information on how the agency intends to interpret and apply provisions of the existing regulations regarding internal agency review of decisions. In addition, the guidance outlines the established recommended procedures for persons who are applicants, including sponsor applicants or manufacturers, for animal drugs or other products regulated by CVM, that wish to submit a request for review of a scientific dispute. When an applicant has a scientific disagreement and a written decision by CVM, the applicant may submit a request for review of that decision by following the established agency channels of supervision for review. Respondents to this collection of information are applicants that wish to submit a request for review of a scientific dispute. In the Federal Register of March 26, 2008 (73 FR 16021), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of respondents 21 CFR section 10.75 2 1There Dated: June 19, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–14515 Filed 6–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting rfrederick on PROD1PC67 with NOTICES Total annual responses 4 Hours per response 8 Total hours 10 80 are no capital costs or operating and maintenance costs associated with this collection of information. This estimated annual reporting burden is based on CVM’s experience over the past 3 years in handling formal appeals for scientific disputes. The number of respondents multiplied by the annual frequency of response equals the total annual responses. The number of hours per response is based on discussions with industry and may vary depending on the complexity of the issue(s) involved and the duration of the appeal process. AGENCY: Food and Drug Administration, HHS. ACTION: Annual frequency per response Notice. This notice announces a forthcoming meeting of a public advisory committee VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 18, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Louise E. Magruder, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–1248, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512515. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 about possible modifications before coming to the meeting. Agenda: The committee will discuss and make recommendations on issues relevant to the potential for automated differential cell counters being waived under the Clinical Laboratory Improvement Amendments of 1988. The discussion will include pre-analytical, analytical, and post-analytical issues associated with performing automated hematology complete blood counts and differentials in a waived setting. (See www.fda.gov/cdrh/oivd/guidance/ 1171.html). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 73, Number 124 (Thursday, June 26, 2008)]
[Notices]
[Pages 36331-36332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14515]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0173]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary 
Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
28, 2008.

[[Page 36332]]


ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0566. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Appeals of Science-Based Decisions Above the Division Level at the 
Center for Veterinary Medicine (OMB Control Number 0910-0566)--
Extension

    CVM's (Center for Veterinary Medicine) ``Guidance for Industry 
79--Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' describes 
the process by which CVM formally resolves disputes relating to 
scientific controversies. A scientific controversy involves issues 
concerning a specific product regulated by CVM related to matters of 
technical expertise and requires specialized education, training or 
experience to be understood and resolved. Further, the guidance details 
information on how the agency intends to interpret and apply provisions 
of the existing regulations regarding internal agency review of 
decisions. In addition, the guidance outlines the established 
recommended procedures for persons who are applicants, including 
sponsor applicants or manufacturers, for animal drugs or other products 
regulated by CVM, that wish to submit a request for review of a 
scientific dispute. When an applicant has a scientific disagreement and 
a written decision by CVM, the applicant may submit a request for 
review of that decision by following the established agency channels of 
supervision for review.
    Respondents to this collection of information are applicants that 
wish to submit a request for review of a scientific dispute.
    In the Federal Register of March 26, 2008 (73 FR 16021), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual frequency       Total annual        Hours per
                    21 CFR section                         respondents         per response          responses           response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75                                                                   2                     4                  8                 10                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimated annual reporting burden is based on CVM's experience 
over the past 3 years in handling formal appeals for scientific 
disputes. The number of respondents multiplied by the annual frequency 
of response equals the total annual responses. The number of hours per 
response is based on discussions with industry and may vary depending 
on the complexity of the issue(s) involved and the duration of the 
appeal process.

    Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14515 Filed 6-25-08; 8:45 am]
BILLING CODE 4160-01-S