Agency Information Collection Activities: Submission For OMB Review; Comment Request, 42419-42420 [E7-14928]

Download as PDF 42419 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices TABLE 2.—FY 2008 FEE RATES—Continued Animal Drug User Fee Category Fee Rate for FY 2008 Animal Drug Establishment Fee1 Animal Drug Sponsor 1An 2An $52,700 Fee2 $43,900 animal drug establishment is subject to only one such fee each FY. animal drug sponsor is subject to only one such fee each FY. mstockstill on PROD1PC66 with NOTICES X. Procedures for Paying the FY 2008 Fees day, using the Payment Identification Number described previously. A. Application Fees and Payment Instructions The appropriate application fee established in the new fee schedule must be paid for an animal drug application or supplement subject to fees under ADUFA that is submitted 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. On your check, bank draft, or U.S. postal money order, please write your application’s unique Payment Identification Number, beginning with the letters AD, from the upper right-hand corner of your completed Animal Drug User Fee Cover Sheet. Also write the FDA post office box number (PO Box 953877) on the enclosed check, bank draft, or money order. Your payment and a copy of the completed Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug Administration, P.O. Box 953877, St. Louis, MO, 63195–3877. If you prefer to send a check by a courier such as FEDEX or UPS, the courier may deliver the check and printed copy of the cover sheet to: US Bank, Attn: Government Lockbox 953877, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. If you have any questions concerning courier delivery contact the US Bank at 314– 418–4821. This phone number is only for questions about courier delivery.) The tax identification number of the Food and Drug Administration is 530196965. (Note: In no case should the check for the fee be submitted to FDA with the application.) It is helpful if the fee arrives at the bank at least a day or two before the application arrives at FDA’s Center for Veterinary Medicine. FDA records the official application receipt date as the later of the following: The date the application was received by FDA’s Center for Veterinary Medicine, or the date US Bank notifies FDA that your check in the full amount of the payment due has been received. US Bank is required to notify FDA within 1 working B. Application Cover Sheet Procedures VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 Step One—Create a user account and password. Log onto the ADUFA Web site at http://www.fda.gov/oc/adufa and, under the ‘‘Forms’’ heading, click on the link ‘‘User Fee Cover Sheet.’’ For security reasons, each firm submitting an application will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process. Step Two—Create an Animal Drug User Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with your user name and password, complete the steps required to create an Animal Drug User Fee Cover Sheet. One cover sheet is needed for each animal drug application or supplement. Once you are satisfied that the data on the cover sheet is accurate and you have finalized the cover sheet, you will be able to transmit it electronically to FDA and you will be able to print a copy of your cover sheet showing your unique Payment Identification Number. Step Three—Send the Payment for your application as described in section X.A of this document. Step Four—Please submit your application and a copy of the completed Animal Drug User Fee Cover Sheet to the following address: Food and Drug Administration, Center for Veterinary Medicine, Document Control Unit (HFV–199), 7500 Standish Pl., Rockville, MD 20855. C. Product, Establishment and Sponsor Fees By December 30, 2007, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2008 using this Fee Schedule. Payment will be due and payable by January 31, 2008. FDA will issue invoices in October 2008 for any products, establishments, and sponsors subject to fees for FY 2008 that qualify for fees after the December 2007 billing. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Dated: July 27, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. 07–3782 Filed 7–30–07; 4:29 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission For OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The Smallpox Vaccine Injury Compensation Program (OMB No. 0915–0282)—Extension The Smallpox Emergency Personnel Protection Act (SEPPA) authorized the Secretary of Health and Human Services to establish The Smallpox Vaccine Injury Compensation Program, which provides benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. The benefits available under the Program include compensation for unreimbursed medical care expenses, lost employment income, and survivor death benefits. To be considered for Program benefits, requesters (i.e., smallpox vaccine recipients, vaccinia contacts, survivors, or the representatives of the estates of deceased smallpox vaccine recipients or vaccinia contacts), or persons filing on E:\FR\FM\02AUN1.SGM 02AUN1 42420 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices their behalf as their representatives, must file a Request Form and the documentation required under SEPPA and its implementing regulations (42 CFR Part 102) to show that they are eligible. Requesters must submit appropriate documentation to allow the Secretary to determine if the requesters are eligible for Program benefits. This documentation will vary somewhat depending on whether the requester is filing as a smallpox vaccine recipient, a vaccinia contact, a survivor, or a representative of an estate. Number of respondents Form Responses per respondent All requesters must submit medical records sufficient to demonstrate that a covered injury was sustained by a smallpox vaccine recipient or a vaccinia contact. The Estimated Annual Burden is as follows: Total responses Hours per response Total burden hours Request Form ...................................................................... Certification .......................................................................... 25 25 1 1 25 25 5 1 125 25 Total .............................................................................. 25 ........................ 25 ........................ 150 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: July 25, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–14928 Filed 8–1–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration mstockstill on PROD1PC66 with NOTICES National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its fifty-seventh meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Times: September 12, 2007, 8 a.m.–5:30 p.m.; September 13, 2007, 8 a.m.–5 p.m.; September 14, 2007, 8 a.m.–11 a.m. Place: Best Western Inn on the Park, 22 South Carroll Street, Madison, WI 53703, Phone: 608–257–8811. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and administration of VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 health and human services in rural areas. upcoming February meeting. The meeting will be adjourned at 11 a.m. Agenda: Wednesday morning, at 8 a.m., the meeting will be called to order by the Chairperson of the Committee, the Honorable David Beasley. The first session will be a snapshot of Wisconsin, focusing on the challenges related to jobs, income, and educational level and a look at health and human services assets and liabilities. The next presentation will examine collaborative approaches to increase the supply of physicians for rural Wisconsin. Following this presentation will be discussions on State Medicaid waivers to improve access to healthcare and welfare reform. The next presentation will be a panel discussion by Toyota on health and human services integration in Tupelo, Mississippi, and the implications on the community of the new Toyota factory. The Committee will break into Subcommittee format for the remainder of the day’s meeting. The Wednesday meeting will close at 5:30 p.m. FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the Committee should contact Tom Morris, M.P.A., Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, Room 9A–55, 5600 Fishers Lane, Rockville, MD 20857, telephone (301) 443–0835, Fax (301) 443–2803. Thursday morning, September 13, at 8 a.m., the Committee will meet briefly to discuss the site visit. At 8:30 a.m., the Committee will depart for Sauk City, Wisconsin. The Committee will hear presentations on health and human services issues facing the community. Transportation to the site visit will not be provided. The Committee will return to the Best Western Inn on the Park to resume the meeting in Subcommittee format at 2 p.m. The Thursday meeting will close at 5 p.m. BILLING CODE 4165–15–P The final session will be convened Friday morning, September 14, at 8 a.m. The Committee will have a discussion on the site visit. Following this discussion will be a report by the Subcommittees on the progress with the report chapters; discussion on the letter to the Secretary; and discussion on the PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Persons interested in attending any portion of the meeting should contact Michele Pray-Gibson, Office of Rural Health Policy (ORHP), telephone (301) 443–0835. The Committee meeting agenda will be posted on ORHP’s Web site http://www.ruralhealth.hrsa.gov. Dated: July 24, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–14927 Filed 8–1–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42419-42420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14928]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission For OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301) 443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: The Smallpox Vaccine Injury Compensation Program (OMB 
No. 0915-0282)--Extension

    The Smallpox Emergency Personnel Protection Act (SEPPA) authorized 
the Secretary of Health and Human Services to establish The Smallpox 
Vaccine Injury Compensation Program, which provides benefits and/or 
compensation to certain persons harmed as a direct result of receiving 
smallpox covered countermeasures, including the smallpox vaccine, or as 
a direct result of contracting vaccinia through certain accidental 
exposures.
    The benefits available under the Program include compensation for 
unreimbursed medical care expenses, lost employment income, and 
survivor death benefits. To be considered for Program benefits, 
requesters (i.e., smallpox vaccine recipients, vaccinia contacts, 
survivors, or the representatives of the estates of deceased smallpox 
vaccine recipients or vaccinia contacts), or persons filing on

[[Page 42420]]

their behalf as their representatives, must file a Request Form and the 
documentation required under SEPPA and its implementing regulations (42 
CFR Part 102) to show that they are eligible.
    Requesters must submit appropriate documentation to allow the 
Secretary to determine if the requesters are eligible for Program 
benefits. This documentation will vary somewhat depending on whether 
the requester is filing as a smallpox vaccine recipient, a vaccinia 
contact, a survivor, or a representative of an estate.
    All requesters must submit medical records sufficient to 
demonstrate that a covered injury was sustained by a smallpox vaccine 
recipient or a vaccinia contact.
    The Estimated Annual Burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Request Form....................              25               1              25               5             125
Certification...................              25               1              25               1              25
                                 -------------------------------------------------------------------------------
    Total.......................              25  ..............              25  ..............             150
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: July 25, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
 [FR Doc. E7-14928 Filed 8-1-07; 8:45 am]
BILLING CODE 4165-15-P