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Federal Register / Vol. 72, No.

148 / Thursday, August 2, 2007 / Notices 42419

TABLE 2.—FY 2008 FEE RATES—Continued


Animal Drug User Fee Category Fee Rate for FY 2008

Animal Drug Establishment Fee1 $52,700

Animal Drug Sponsor Fee2 $43,900


1An animal drug establishment is subject to only one such fee each FY.
2An animal drug sponsor is subject to only one such fee each FY.

X. Procedures for Paying the FY 2008 day, using the Payment Identification Dated: July 27, 2007.
Fees Number described previously. Randall W. Lutter,
Deputy Commissioner for Policy.
A. Application Fees and Payment B. Application Cover Sheet Procedures
Instructions [FR Doc. 07–3782 Filed 7–30–07; 4:29 pm]
Step One—Create a user account and BILLING CODE 4160–01–S
The appropriate application fee password. Log onto the ADUFA Web
established in the new fee schedule site at http://www.fda.gov/oc/adufa and,
must be paid for an animal drug under the ‘‘Forms’’ heading, click on the DEPARTMENT OF HEALTH AND
application or supplement subject to link ‘‘User Fee Cover Sheet.’’ For HUMAN SERVICES
fees under ADUFA that is submitted security reasons, each firm submitting
after September 30, 2007. Payment must an application will be assigned an Health Resources and Services
be made in U.S. currency by check, organization identification number, and Administration
bank draft, or U.S. postal money order each user will also be required to set up
payable to the order of the Food and Agency Information Collection
a user account and password the first
Drug Administration. On your check, Activities: Submission For OMB
time you use this site. Online
bank draft, or U.S. postal money order, Review; Comment Request
instructions will walk you through this
please write your application’s unique process. Periodically, the Health Resources
Payment Identification Number, Step Two—Create an Animal Drug and Services Administration (HRSA)
beginning with the letters AD, from the User Cover Sheet, transmit it to FDA, publishes abstracts of information
upper right-hand corner of your and print a copy. After logging into your collection requests under review by the
completed Animal Drug User Fee Cover account with your user name and Office of Management and Budget
Sheet. Also write the FDA post office password, complete the steps required (OMB), in compliance with the
box number (PO Box 953877) on the to create an Animal Drug User Fee Paperwork Reduction Act of 1995 (44
enclosed check, bank draft, or money Cover Sheet. One cover sheet is needed U.S.C. Chapter 35). To request a copy of
order. Your payment and a copy of the for each animal drug application or the clearance requests submitted to
completed Animal Drug User Fee Cover supplement. Once you are satisfied that OMB for review, call the HRSA Reports
Sheet can be mailed to: Food and Drug the data on the cover sheet is accurate Clearance Office on (301) 443–1129.
Administration, P.O. Box 953877, St. and you have finalized the cover sheet, The following request has been
Louis, MO, 63195–3877. you will be able to transmit it submitted to the Office of Management
If you prefer to send a check by a and Budget for review under the
electronically to FDA and you will be
courier such as FEDEX or UPS, the Paperwork Reduction Act of 1995:
able to print a copy of your cover sheet
courier may deliver the check and
showing your unique Payment Proposed Project: The Smallpox
printed copy of the cover sheet to: US
Identification Number. Vaccine Injury Compensation Program
Bank, Attn: Government Lockbox
953877, 1005 Convention Plaza, St. Step Three—Send the Payment for (OMB No. 0915–0282)—Extension
Louis, MO 63101. (Note: This address is your application as described in section The Smallpox Emergency Personnel
for courier delivery only. If you have X.A of this document. Protection Act (SEPPA) authorized the
any questions concerning courier Step Four—Please submit your Secretary of Health and Human Services
delivery contact the US Bank at 314– application and a copy of the completed to establish The Smallpox Vaccine
418–4821. This phone number is only Animal Drug User Fee Cover Sheet to Injury Compensation Program, which
for questions about courier delivery.) the following address: Food and Drug provides benefits and/or compensation
The tax identification number of the Administration, Center for Veterinary to certain persons harmed as a direct
Food and Drug Administration is Medicine, Document Control Unit result of receiving smallpox covered
530196965. (Note: In no case should the (HFV–199), 7500 Standish Pl., countermeasures, including the
check for the fee be submitted to FDA Rockville, MD 20855. smallpox vaccine, or as a direct result of
with the application.) C. Product, Establishment and Sponsor contracting vaccinia through certain
It is helpful if the fee arrives at the Fees accidental exposures.
bank at least a day or two before the The benefits available under the
application arrives at FDA’s Center for By December 30, 2007, FDA will issue Program include compensation for
Veterinary Medicine. FDA records the invoices and payment instructions for unreimbursed medical care expenses,
official application receipt date as the product, establishment, and sponsor lost employment income, and survivor
later of the following: The date the fees for FY 2008 using this Fee death benefits. To be considered for
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application was received by FDA’s Schedule. Payment will be due and Program benefits, requesters (i.e.,
Center for Veterinary Medicine, or the payable by January 31, 2008. FDA will smallpox vaccine recipients, vaccinia
date US Bank notifies FDA that your issue invoices in October 2008 for any contacts, survivors, or the
check in the full amount of the payment products, establishments, and sponsors representatives of the estates of
due has been received. US Bank is subject to fees for FY 2008 that qualify deceased smallpox vaccine recipients or
required to notify FDA within 1 working for fees after the December 2007 billing. vaccinia contacts), or persons filing on

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42420 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices

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

Responses
Number of Total Hours per Total burden
Form per
respondents responses response hours
respondent

Request Form ...................................................................... 25 1 25 5 125


Certification .......................................................................... 25 1 25 1 25

Total .............................................................................. 25 ........................ 25 ........................ 150

Written comments and health and human services in rural upcoming February meeting. The
recommendations concerning the areas. meeting will be adjourned at 11 a.m.
proposed information collection should Agenda: Wednesday morning, at 8 FOR FURTHER INFORMATION CONTACT:
be sent within 30 days of this notice to a.m., the meeting will be called to order
the desk officer for HRSA, either by Anyone requiring information regarding
by the Chairperson of the Committee, the Committee should contact Tom
e-mail to the Honorable David Beasley. The first
OIRA_submission@omb.eop.gov or by Morris, M.P.A., Executive Secretary,
session will be a snapshot of Wisconsin, National Advisory Committee on Rural
fax to 202–395–6974. Please direct all focusing on the challenges related to
correspondence to the ‘‘attention of the Health and Human Services, Health
jobs, income, and educational level and Resources and Services Administration,
desk officer for HRSA.’’
a look at health and human services Parklawn Building, Room 9A–55, 5600
Dated: July 25, 2007. assets and liabilities. The next Fishers Lane, Rockville, MD 20857,
Alexandra Huttinger, presentation will examine collaborative telephone (301) 443–0835, Fax (301)
Acting Director, Division of Policy Review approaches to increase the supply of
and Coordination.
443–2803.
physicians for rural Wisconsin.
[FR Doc. E7–14928 Filed 8–1–07; 8:45 am] Following this presentation will be Persons interested in attending any
BILLING CODE 4165–15–P discussions on State Medicaid waivers portion of the meeting should contact
to improve access to healthcare and Michele Pray-Gibson, Office of Rural
welfare reform. The next presentation Health Policy (ORHP), telephone (301)
DEPARTMENT OF HEALTH AND will be a panel discussion by Toyota on 443–0835. The Committee meeting
HUMAN SERVICES health and human services integration agenda will be posted on ORHP’s Web
in Tupelo, Mississippi, and the site http://www.ruralhealth.hrsa.gov.
Health Resources and Services
implications on the community of the Dated: July 24, 2007.
Administration
new Toyota factory. The Committee will
Alexandra Huttinger,
National Advisory Committee on Rural break into Subcommittee format for the
remainder of the day’s meeting. The Acting Director, Division of Policy Review
Health and Human Services; Notice of and Coordination.
Meeting Wednesday meeting will close at 5:30
p.m. [FR Doc. E7–14927 Filed 8–1–07; 8:45 am]
In accordance with section 10(a)(2) of BILLING CODE 4165–15–P
Thursday morning, September 13, at 8
the Federal Advisory Committee Act
a.m., the Committee will meet briefly to
(Pub. L. 92–463), notice is hereby given
discuss the site visit. At 8:30 a.m., the DEPARTMENT OF HEALTH AND
that the following committee will
Committee will depart for Sauk City, HUMAN SERVICES
convene its fifty-seventh meeting.
Name: National Advisory Committee Wisconsin. The Committee will hear
on Rural Health and Human Services. presentations on health and human Substance Abuse and Mental health
Dates and Times: September 12, 2007, services issues facing the community. Services Administration
8 a.m.–5:30 p.m.; September 13, 2007, 8 Transportation to the site visit will not
a.m.–5 p.m.; September 14, 2007, 8 be provided. The Committee will return Agency Information Collection
a.m.–11 a.m. to the Best Western Inn on the Park to Activities: Submission for OMB
Place: Best Western Inn on the Park, resume the meeting in Subcommittee Review; Comment Request
22 South Carroll Street, Madison, WI format at 2 p.m. The Thursday meeting
53703, Phone: 608–257–8811. will close at 5 p.m. Periodically, the Substance Abuse and
Status: The meeting will be open to The final session will be convened Mental Health Services Administration
the public. Friday morning, September 14, at 8 a.m. (SAMHSA) will publish a summary of
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Purpose: The National Advisory The Committee will have a discussion information collection requests under
Committee on Rural Health and Human on the site visit. Following this OMB review, in compliance with the
Services provides advice and discussion will be a report by the Paperwork Reduction Act (44 U.S.C.
recommendations to the Secretary with Subcommittees on the progress with the Chapter 35). To request a copy of these
respect to the delivery, research, report chapters; discussion on the letter documents, call the SAMHSA Reports
development and administration of to the Secretary; and discussion on the Clearance Officer on (240) 276–1243.

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