Published 60 day FRN

42414

Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
guide the development of prevention
and control strategies.
Participation in the data collection is
voluntary and there is no cost to
respondents to participate in the survey
other than their time.

beliefs about HCV infection. The utility
of using HCV nucleic acid testing
(NAT), antigen-antibody testing and
other testing modalities to identify seroincident (window period) infections
will also be assessed. Knowledge of
factors associated with acquiring
hepatitis C virus infection is essential to

respondents. The total annual burden
for this project is expected to be 1600
hours. The information to be collected
includes demographic data, risk factors
for HCV infection, missed opportunities
for prevention (including hepatitis A
and B vaccination), access to medical
care, and knowledge, attitudes, and

ESTIMATED ANNUALIZED BURDEN HOURS
Respondents

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Young injection drug users ..............................................................................

1600

1

1

1600

Dated: July 27, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–15020 Filed 8–1–07; 8:45 am]

agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

Proposed Project

[60 Day-07–0020]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an email to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the

Coal Workers’ X-ray Surveillance
Program (CWXSP) OMB # 0920–0020—
Extension—The National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The CWXSP is a federally mandated
program under the Federal Mine Safety
and Health Act of 1977, Public Law 95–
164. The Act provides the regulatory
authority for the administration of the
CWXSP, a surveillance program to
protect the health and safety of
underground coal miners. This Program
requires the gathering of demographic
and logistical information from coal
mine operators, participating miners,
participating x-ray facilities, and
participating physicians. The
Appalachian Laboratory for
Occupational Safety and Health
(ALOSH), located in Morgantown, WV,
is charged with administration of this
Program. Over the past two years,
participation in the CWXSP has
increased, which is reflected in this

submission for renewal. Based on an
average of 5,000 x-rays coming into the
Program per year (each x-ray receives
two readings), and using the average
hourly wage rates taken from the Bureau
of Labor Statistics, National
Occupational Employment and Wage
Estimates, the total annualized burden
hours is 2,329. Physicians (B Readers)
will fill out forms regarding their
interpretations of the x-rays. Based on
prior practice it takes the physician
approximately 3 minutes per form.
Physicians taking the B Reader
Examination are asked to complete a
registration form which takes
approximately 10 minutes to complete.
There are approximately 300 physicians
each year taking the certification exam.
Miners participating in the CWXSP
must fill out the Miner Identification
Document which requires
approximately 20 minutes. There are
about 5,000 miners participating in the
CWXSP Program. Mine operators are
required to file a Mine x-ray Plan with
NIOSH approximately every 3 years. It
takes the mine operator approximately
30 minutes to complete this form.
Approximately 200 mine operators have
x-ray plans that are due for renewal
each year. An x-ray facility that applies
to be a NIOSH-approved facility for
providing miners x-rays must complete
an approval packet. The forms
associated with this approval process
require approximately 30 minutes for
completion. There are approximately 25
x-ray facilities each year seeking
approval into the CWXSP Program.
Overall, there will be no costs to study
participants.

mstockstill on PROD1PC66 with NOTICES

ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

Physicians/interpretations ................................................................................

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Average
burden/response
(in hrs.)

Number of
responses/
respondent

10,000

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1

02AUN1

3/60

Total burden
(in hrs.)
500

42415

Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued

Total burden
(in hrs.)

Physicians/certification .....................................................................................
Miners ..............................................................................................................
Mine operators .................................................................................................
X-ray facilities ..................................................................................................

300
5000
200
25

1
1
1
1

10/60
20/60
30/60
30/60

50
1,666
100
13

Total ..........................................................................................................

........................

........................

........................

2,329

Dated: July 27, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–15027 Filed 8–1–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2008
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

mstockstill on PROD1PC66 with NOTICES

Average
burden/response
(in hrs.)

Number of
responses/
respondent

Number of
respondents

Respondents

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2008 animal drug user fees.
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the Animal
Drug User Fee Act of 2003 (ADUFA),
authorizes FDA to collect user fees for
certain animal drug applications, on
certain animal drug products, on certain
establishments where such products are
made, and on certain sponsors of such
animal drug applications and/or
investigational animal drug
submissions. This notice establishes the
fee rates for FY 2008.
For FY 2008, the animal drug user fee
rates are: $172,500 for an animal drug
application; $86,250 for a supplemental
animal drug application for which
safety or effectiveness data is required;
$4,125 for an annual product fee;
$52,700 for an annual establishment fee;
and $43,900 for an annual sponsor fee.
FDA will issue invoices for FY 2008
product, establishment and sponsor fees
by December 30, 2007, and these
invoices will be due and payable by
January 31, 2008.
The application fee rates are effective
for applications submitted on or after
October 1, 2007, and will remain in
effect through September 30, 2008.
Applications will not be accepted to
review until FDA has received full

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17:42 Aug 01, 2007

Jkt 211001

payment of application fees and any
other animal drug user fees owed.
FOR FURTHER INFORMATION CONTACT: Visit
the FDA Web site at http://www.fda.gov/
oc/adufa or contact Roxanne
Schweitzer, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7529 Standish Pl.,
Rockville, MD 20855, 240–276–9705.
For general questions, you may also email the Center for Veterinary Medicine
(CVM) at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the act (21 U.S.C. 379j–
12) establishes four different kinds of
user fees: (1) Fees for certain types of
animal drug applications and
supplements, (2) annual fees for certain
animal drug products, (3) annual fees
for certain establishments where such
products are made, and (4) annual fees
for certain sponsors of animal drug
applications and/or investigational
animal drug submissions (21 U.S.C.
379j–12(a)). When certain conditions are
met, FDA will waive or reduce fees (21
U.S.C. 379j–12(d)).
For FY 2004 through FY 2008, the act
establishes aggregate yearly base
revenue amounts for each of these fee
categories. Base revenue amounts
established for years after FY 2004 are
subject to adjustment for inflation and
workload. Fees for applications,
establishments, products, and sponsors
are to be established each year by FDA
so that the revenue for each fee category
will approximate the level established
in the statute, after the level has been
adjusted for inflation and workload.
II. Revenue Amount for FY 2008 and
Adjustments for Inflation and
Workload
A. Statutory Fee Revenue Amounts
ADUFA (Public Law 108–130)
specifies that the aggregate revenue
amount for FY 2008 for each of the four
animal drug user fee categories is
$2,500,000, before any adjustments for
inflation or workload are made (21
U.S.C. 379j–12(b)(1)–(4)).

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B. Inflation Adjustment to Fee Revenue
Amount
ADUFA provides that fee revenue
amounts for each FY after 2004 shall be
adjusted for inflation (see 21 U.S.C.
379j–12(c)(1)). The adjustment must
reflect the greater of the following: (1)
The total percentage change that
occurred in the Consumer Price Index
(CPI) for all urban consumers (all items;
U.S. city average) during the 12-month
period ending June 30 preceding the FY
for which fees are being set, or (2) the
total percentage pay change for the
previous FY for Federal employees
stationed in Washington, DC. ADUFA
provides for this annual adjustment to
be cumulative and compounded
annually after FY 2004 (21 U.S.C. 379j–
12(c)(1)).
The inflation adjustment for FY 2005
was 4.42 percent. This was the greater
of the CPI increase during the 12-month
period ending June 30, 2004, (3.27
percent) or the increase in pay for FY
2004 for Federal employees stationed in
Washington, DC (4.42 percent).
The inflation adjustment for FY 2006
was 3.71 percent. This was the greater
of the CPI increase during the 12-month
period ending June 30, 2005, (2.53
percent) or the increase in pay for FY
2005 for Federal employees stationed in
Washington, DC (3.71 percent).
The inflation adjustment for FY 2007
was 4.32 percent. This was the greater
of the CPI increase for the 12-month
period ending June 30, 2006, (4.32
percent) or the increase in pay for FY
2006 for Federal employees stationed in
Washington, DC (3.44 percent).
The inflation adjustment for FY 2008
is 2.69 percent. This is the greater of the
CPI increase for the 12-month period
ending June 30, 2007, (2.69 percent) or
the increase in pay for FY 2007 for
Federal employees stationed in
Washington, DC (2.64 percent).
Compounding these amounts (1.0442
times 1.0371 times 1.0432 times 1.0269)
yields a total compounded inflation
adjustment of 16.01 percent for FY
2008.

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