1 1. IDENTIFICATION OF THE INFORMATION COLLECTION ( a) Title of the Information Collection This information collection request is for the new Environmental Protection Agency ( EPA) requirement entitled " Background Checks for Contractor Employees ( Renewal)," EPA ICR Number 2159.02 and OMB Control Number 2030 0043 The Agency requires background checks for specified contractor employees working in sensitive locations or sensitive projects and not otherwise covered by a background check in accordance with Homeland Security Presidential Directive  12.

( b) Short Characterization The EPA uses contractors to perform services throughout the nation with regard to environmental emergencies involving the release, or threatened release, of oil, radioactive materials or hazardous chemicals that may potentially affect communities and the surrounding environment. Releases may be accidental, deliberate, or may be caused by natural disasters. The Agency may request contractors responding to any of these types of incidents to conduct background checks and apply Government established suitability criteria in determining whether employees are acceptable to perform on given sites or on specific projects. In addition to emergency response contractors, EPA may require background checks for contractor personnel working in sensitive sites or sensitive projects. The background checks and application of the Government's suitability criteria must be completed prior to contract employee performance. The contractor shall maintain records associated with all background checks.

2. NEED FOR AND USE OF THE COLLECTION ( a) Need/ authority for the Collection The legal authority for this collection is Title 5, Code of Federal Regulations, Parts 731, 732, and 736. The EPA has a responsibility to protect the public, Agency employees, and contractors through a background check and application of Government established suitability criteria to ensure reliability, trustworthiness, and good conduct and character. This process is necessary to allow the EPA to meet its responsibilities and mitigate the threat to the public health, welfare and the environment.

( b) Uses/ users of the Data Information collected by contractors for performing background checks is necessary for applying the Government established suitability criteria on contract employees before the individual employees perform contractual services for the EPA. 2 3. NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA ( a) Nonduplication Information requested from a contractor's employee to determine suitability to perform on a response contract is unique to a specific individual; this information cannot be obtained from any other source.

( b) Public Notice Required Prior to ICR submission to the Office of Management and Budget.

The information collection request has been published as a Notice in the Federal Register on June 10, 2005. No comments were received.

( c) Consultations To determine contractor burden associated with the information collection identified in this request, the following vendors were contacted:

Representative Firm Phone Mr. Bradley Cunningham WRS Infrastructure& Env. ( 267) 540 0048 Ms Cindy Sengo Project Resources, Inc. ( 858) 505 1000 Mr. Bill McGowan Earth Tech, Inc. ( 805) 515 8501 Each individual consulted indicated that he/ she understood the need for the information collection and did not find the collection excessively burdensome. Estimated time to complete the information collection is described in section 6. Estimating the Burden and Cost of the Collection."

( d) Effects of Less Frequent Collection The information provided by the contractors' employees is collected once prior to the employee performing work for EPA. The requirement for a background check and application of the Government's suitability criteria cannot be met with a less frequent collection.

( e) General Guidelines The information contained in this ICR is in accordance with the Office of Management and Budget's general guidelines for Federal data collection, except that small entities have to follow the same collection procedures as other respondents.

( f) Confidentiality 3 The EPA contractor is responsible for collecting and maintaining information under this collection of information; therefore, each contractor will have his own procedures for ensuring confidentiality.

( g) Sensitive Questions Information requested is commonly collected as a normal business practice. The contractor will collect and maintain employee information. The EPA will not collect contractor employee information nor maintain it. The Agency is responsible for receiving the suitability notification from contractors.

If a contractor employee's background check does not meet the suitability criteria, but the contractor wants the employee to work on the response site, the contractor must submit a waiver request to the Director, Superfund/ RCRA Regional Procurement Operations Division ( SRRPOD). The information submitted to SRRPOD is maintained and protected in accordance with Privacy Act requirements.

4. THE RESPONDENTS AND THE INFORMATION RECEIVED ( a) Respondents/ North American Industry Classification System Codes Information is collected for employees of the contractor and subcontractor who perform work in sensitive sites or sensitive projects. All contractor employees who will perform on response action are subject to a background check and must meet the Government established suitability criteria prior to contract performance. Typically, these contractor respondents fall into the following North American Industry Classification System code: 562910 Remediation Services. Other contractors may be subject to background check requirements.

( b) Information Requested The contractor's employees will be required to provide information such as name, social security number, proof of US citizenship or legal resident status, employment history, education, military service, and address of residence.

After performing a background check and applying the Government's suitability criteria for an employee, the contractor must notify the contracting officer that the background checks and the application the Government's suitability criteria have been completed and that named individuals are suitable to work on a specific contract.

5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT ( a) Agency Activities 4 EPA contracting officers are responsible for ensuring that they have received notification from the contractor that all of its employees working under the emergency response contract at an incident have undergone a background check and have met the Government established suitability criteria.

( b) Collection Methodology and Management The information is collected by each contractor from each employee who will be working at sensitive sites or in sensitive positions which could involve law enforcement activities, indoor cleanups ( including occupied household residences), drug lab cleanups , and emergency response actions at geographically sensitive locations such at military installations and Government buildings. Submissions are accepted in any format so long as they include the requested data. No information is submitted to the Agency, but compliance is mandatory and no employee may work on a response site without meeting the Government established suitability criteria unless the requirement has been waived by the contracting officer. Contracting officers, on a case by case basis, may, either temporarily or permanently, waive the requirements, if they determine, in writing, that these requirements are not necessary at a specific location, or for a specific individual, in order to protect the Government's interests. The suitability criteria has been developed by the Government to determine that there are reasonable grounds to believe that an individual will likely be able to perform the contract requirements on a sensitive site or in a sensitive position without undue risk to the interests of the Government. Once the contractor has applied the criteria and the employee has met the requirements as prescribed in the Statement of Work, contractors must notify the EPA contracting officer. Contractors must maintain the records of their background checks and application of the Agency's suitability criteria.

( c) Small Entity Flexibility Separate or further simplified requirements for small entities are not practical because the stated objectives cannot be met under such alternatives. The requirements of the information collection apply to the awardee of the contract. Reasonable expense associated with the EPA background checks is reimbursable; therefore, small businesses are not expected to experience financial difficulties in fulfilling these requirements. There are numerous commercial sources that perform background checks.

( d) Collection Schedule Information will be collected periodically as individuals are requested to work at a sensitive site or in a sensitive position under new or existing contracts.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION ( a) Estimation of Respondent Burden Respondent burden estimates for this collection are based upon interviews with the 5 contractors identified in 3( c) above and discussions with Agency personnel. The Agency anticipates that the contractor burden for complying with this requirement includes the time it takes for employees to provide the required information, the time to manage a subcontract for background checks, the administrative time to apply the Government's suitability criteria, the time to notify the Agency, and the effort to maintain the records.

( b) Estimation of Respondent Costs ( i) Estimating Labor Costs Respondent Cost Estimate Respondent Cost Estimate Burden Loaded Step Collection Activity Labor Cat. Hours Rate Cost 1. Time to fill out information Employees .25 hour $ 58.94 $ 14.74 2. Cost to perform Background $ 100.00 Check ( Subcontract) 3. Review/ apply Manager .25 hour $ 106.91 $ 26.73 suitability criteria 4. Submit notification Manager .25 hour $ 106.91 $ 26.73 5. Maintain files Amin. Support .25 hour $ 43.96 $ 10.99 1.0 hours $ 179.19 Step 1 of the information collection is completed by an employee at any level working onsite Steps 2 is a plug figure based upon market research. This may be performed in house or contracted out to a third party. Step 3 and 4 of the collection activity is performed by an administrative manager responsible for personnel management. Administrative support personnel are responsible for completing step 5.

The cost associated with this effort was estimated using a loaded hourly rate based upon the National Compensation Survey: Occupational Wages in the United States, 2003 published by the U. S. Department of Labor, Bureau of Labor Statistics in August of 2004, and represents the most current survey data available.

Since the labor rates used in this estimate are from 2003, an escalation factor of 4% ( based upon Defense Contract Audit Agency) was applied for each year to determine an average wage for the respective year. The cost for each labor category was determined by multiplying the escalated hourly labor rate by an estimated loading factor of 2.95 (* see below) to reflect industries' over head, fringe benefits, and general and administrative costs for each year ( 2005 thru 2007) that the ICR will be in effect. These loaded labor cost for 2005 thru 2007 are then divided by three ( number of years for the ICR) to arrive at an annualized labor cost for each labor category. 6 The following are the loaded labor rates used in the calculations in the table above:

Employees: 2003 = $ 17.75 2004 = ($ 17.75 x 1.04) $ 18.46 2005 = ($ 18.46 x 1.04) $ 19.20 x 2.95 = $ 56.64 2006 = ($ 19.20 x 1.04) $ 19.97 x 2.95 = $ 58.91 2007 = ($ 19.97 x 1.04) $ 20.77 x 2.95 = $ 61.27 $ 176.82/ 3 = $ 58.94 Administrative Manager: 2003 = $ 32.20 2004 = ($ 32.20 x 1.04) $ 33.49 2005 = ($ 33.49 x 1.04) $ 34.83 x 2.95 = $ 102.75 2006 = ($ 34.83 x 1.04) $ 36.22 x 2.95 = $ 106.85 2007 = ($ 36.22 x 1.04) $ 37.67 x 2.95 = $ 111.13 $ 320.73/ 3 = $ 106.91 Administrative Support: 2003 = $ 13.77 2004 = ($ 13.77 x 1.04) $ 13.23 2005 = ($ 13.23 x 1.04) $ 14.32 x 2.95 = $ 42.24 2006 = ($ 14.32 x 1.04) $ 14.89 x 2.95 = $ 43.93 2007 = ($ 14.89 x 1.04) $ 15.49 x 2.95 = $ 45.70 $ 131.87/ 3 = $ 43.96 * 2.95 is a factor recommended by EPA cost analyst as representative of labor related burdens experienced by EPA contractors.

( ii) Capital/ Start up Costs Respondents will not be required to acquire capital goods to provide the requested information; therefore, capital start up costs have not been included in this estimate.

( iii) Operating and Maintenance Costs Operating and maintenance costs, which include such items as file storage, photocopying, and postage, will be nominal.

( c) Estimating Agency Burden and Cost Agency burden for responses to background check and application of Government suitability criteria. 7 Agency Burden Cost Estimate Labor Loaded Step Collection Activity Category Burden Hours Rate Cost 1. Ensure Compliance GS 13 5 .25 hour $ 78.00 $ 19.50 2. Document Contractors' GS 13 5 .25 hour $ 78.00 $ 19.50 Notifications .5 hour $ 39.00 * EPA Waiver GS 13 5 .25 hour $ 78.00 $ 19.50 * Requests for waivers are estimated at 25% of contractor employees.

2005 = 35.01 x 2.16** = $ 75.62 2006 = ($ 35.01 x 3.1%) $ 36.10 x 2.16 = $ 77.98 2007 = ($ 36.10 x 3.1%) $ 37.22 x 2.16 = $ 80.40 $ 234.00/ 3 = $ 78.00 Performing background checks and applying the Government's suitability criteria are the responsibility of the EPA contractor. The Agency is primarily responsible for ensuring that contractors notify the Agency that a background check and application of the suitability criteria have been completed for all applicable employees. The Agency's effort is estimated to be at the GS 13 step 5 level. The GS 13 step 5 per hour salary for 2005 is $ 35.01. This per hour wage was escalated by an estimated factor of 3.1% ( compounded) for 2005 and 2006, based upon historical cost of living increases for federal workers. These wage rates were then multiplied by a factor of ** 2.16 to reflect Federal employee benefits and then divided by three for an annualized loaded rate of $ 78.00, for the three years the ICR is in effect ( see above).

** 2.16 is a factor recommended by EPA cost analyst as representative of employee related benefits.

( d) Estimating the Respondent Universe and Total Burden All EPA contractor personnel performing on a response site must provide the required background information unless this requirement is waived by the contracting officer. The number of contractor employees expected to submit the requested information for background checks for the life of this ICR ( 3 years) is 3,000. This number was derived by estimating the number of currently performing contract employees under emergency response contracts. The Agency estimated this number of employees by reviewing current contract databases and information received from all 10 regions. A 10% factor was then applied to cover all other contractor personnel who may work at sensitive sites or sensitive projects.

There are both small and large businesses working in the field with diverse response site situations that require large variations in the number of employees. Contractors may be on site for a few days or many years depending on the situation. There are currently 51 contracts that 8 respond to environmental emergencies involving the release, or threatened release, of oil, radioactive materials or hazardous chemicals that may potentially affect communities and the surrounding environment. Many START, ERRS, REAC and RAC contracts require employees to be prepared to report to work locations. Therefore, these employees must have background checks and meet the Government's suitability criteria even if not continuously located on site.

Additionally, there are contractors working at their own facilities or at other than government locations who work on sensitive locations or on sensitive projects. These may include, but not limited to, maintenance of anti terrorism equipment warehouses, water systems, environmental information, private laboratories working on genetically modified herbicides and pathogens, and law enforcement activities.

Finally, there are situations in which contracting officers may waive this background check requirement, making it difficult to precisely determine the number of respondents. For these reasons, this initial request represents our best estimate given current information. Future estimates will be more accurate and based on historical data monitored through the Agency's contractual systems on the use of the subject clause.

( e) Bottom Line Burden Hours and Costs ( i) Respondent Tally Total annual respondent hours for this collection request is 1,000 hours. This is derived by taking the total number of background checks, 3,000, divided by 3 ( the number of years the ICR is effective for a total of 1,000 occurrences per year. Then the number of annual occurrences, 1,000, is multiplied by the respondent burden effort of 1 hour to collect information to arrive at the total of 1,000 hours per year.

Total annual respondent cost for this collection request is $ 179,000. This is calculated by multiplying the number of annual occurrences, 1,000 by the respondent cost of one collection, $ 179.00 ( ii) The Agency Tally The total annual Agency burden for this collection request is estimated at 500 hours. This is calculated by multiplying the estimated burden hours, .5, by the number of annual occurrences, 1,000 to arrive at 500 hours. Additionally, the estimated number of waivers, 250 ( see below), is multiplied by the estimated time it takes to perform a waiver, .25, to arrive at 62.5 hours per year. The total Agency burden is estimated by adding the contracting officer burden, 500 hours, to the estimated waiver burden, 62.5, to arrive at 562.5 hours per year.

The total annual Agency cost for this collection request is estimated at $ 43,875. This is calculated by adding the cost of the contracting officer effort, $ 39,000 ( see below), plus the estimated cost of the waiver, $ 4,875 ( see below), to arrive at a total Agency burden of $ 43, 875. 9 ( a) Contracting Officer Effort The cost of the contracting officer effort is determined by multiplying the estimated burden hours, .5, by the estimated hourly rate of $ 78.00, for a total of $ 39.00 for one collection request by the contracting officer. The total cost of the contracting officer effort is calculated by multiplying the number of occurrences, 1,000, by the cost for one occurrence, $ 39.00, to arrive at a total estimated cost of $ 39,000.

( b) Estimated Cost of the Waiver Determination Additionally, it is estimated that 25% of contractor employees will have adverse information reported and the contractor will request a waiver. The number of waiver determinations is calculated by multiplying 25% by the number of annual occurrences, 1,000 to arrive at an estimated 250 ( 25% x 1,000) waiver determinations. Then the cost of the waiver determinations is estimated by multiplying the hourly rate of $ 78.00, at the GS 13, step 5 rate, by the .25 hours estimated to make the determination, for a cost of $ 19.50 per occurrence. The total cost of the waiver determination effort is calculated by multiplying the number of occurrences, 250, by the cost for one waiver determination, $ 19.50, to arrive at a total of $ 4,875.00.

( f) Burden Statement The annual public reporting and record keeping burden for this collection of information is estimated to average 1 hour per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OEI 2005 0003, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. 10 Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OEI 2005 0003 and OMB control number: 2030 0043 in any correspondence.


[Federal Register: July 10, 2006 (Volume 71, Number 131)]
[Notices]
[Page 38868-38869]
[DOCID:fr10jy06-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[IC06-714-001, FERC 714]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

June 30, 2006.
AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice.

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SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission) has submitted the information
collection described below to the Office of Management and Budget (OMB)
for review and extension of this information collection requirement.
Any interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
The Commission received no comments in response to an earlier Federal
Register notice of March 30, 2006 (71 FR 16133-16134) and has made this
notation in its submission to OMB.

DATES: Comments on the collection of information are due by August 10,
2006.

ADDRESSES: Address comments on the collection of information to the
Office of Management and Budget, Office of Information and Regulatory
Affairs, Attention: Federal Energy Regulatory Commission Desk Officer.
Comments to OMB should be filed electronically, c/o
<EMAIL_ADDRESS>and include the OMB Control No. as a point of

reference. The Desk Officer may be reached by telephone at 202-395-
4650. A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, Office of the Executive Director, ED-34,
Attention: Michael Miller, 888 First Street, NE., Washington, DC 20426.
Comments may

be filed either in paper format or electronically. Those persons filing
electronically do not need to make a paper filing. For paper filings,
and original and 14 copies of such comments should be submitted to the
Secretary of the Commission, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426 and should refer to Docket No.
IC06-714-001.
    Documents filed electronically via the Internet must be prepared in
WordPerfect, MS Word, Portable Document Format, or ASCII format. To
file the document, access the Commission's Web site at http://www.ferc.gov
 and click on ``Make an E-Filing,'' and then follow the

instructions for each screen. First time users will have to establish a
user name and password. The Commission will send an automatic
acknowledgement to the sender's e-mail address upon receipt of
comments. User assistance for electronic filings is available at 202-
502-8258 or by e-mail to<EMAIL_ADDRESS>Comments should not be
submitted to this e-mail address.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For user assistance, contact
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>. or for TTY,

contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Description

    The information collection submitted for OMB review contains the
following:
    1. Collection of Information: FERC Form 714 ``Annual Electric
Control and Planning Area Report.''
    2. Sponsor: Federal Energy Regulatory Commission.
    3. Control No.: 1902-0140.
    The Commission is now requesting that OMB approve and extend the
expiration date for an additional three years with no changes to the
existing collection. The information filed with the Commission is
mandatory.
    4. Necessity of the Collection of Information: Submission of the
information is necessary for the Commission to carry out its
responsibilities in implementing the Statutory provisions consists of
sections 202, 207, 210, 211-213 of the Federal Power Act (FPA), as
amended (49 Stat. 838; 16 U.S.C. 791a-825r) and particularly sections
304-309 and 311, as well as Energy Policy Act of 2005 (Pub. L. 109-58)
(119 Stat. 594) sections 1211, 1221, 1231, 1241 and 1242. The
Commission implements the Form 714 filing requirements in the Code of
Federal Regulations (CFR) under 18 CFR 141.51.
    Through FERC Form 714, the Commission gathers electric transmission
system operating and planning information, from control area operations
and from utilities charged with resource planning and demand
forecasting for planning areas that have an annual peak demand greater
than 200 megawatts. This information is used in evaluating transmission
system reliability and performance, wholesale rate investigations, and
wholesale market under emerging competitive forces.
    5. Respondent Description: The respondent universe currently
comprises 215 companies (on average) subject to the Commission's
jurisdiction.
    6. Estimated Burden: 10,750 total hours, 215 respondents (average),
1 response per respondent, and 50 hours per response (average)
    7. Estimated Cost Burden to respondents: 10,750 hours/2080 hours
per years x $117,321 per year = $606,347. The cost per respondent is
equal to $2,820.
    Statutory Authority: Statutory provisions of sections 202, 207,
210, 211-213 of the Federal Power Act (FPA), as amend (49 Stat. 838; 16
U.S.C. 791a-825r) and particularly sections 304-309 and 311, as well as
Energy Policy Act of 2005 (Pub. L. 109-58) (119 Stat. 594) sections
1211, 1221, 1231, 1241 and 1242. The Commission implements the Form 714
filing requirements in the Code of Federal Regulations (CFR) under 18
CFR 141.51.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-10695 Filed 7-7-06; 8:45 am]

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[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23782-23783]
[DOCID:fr04my10-96]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Drug Safety and Risk Management Advisory Committee; Notice of
Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Drug Safety and Risk Management 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 September 14, 2010, from
8 a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of
Maryland and University College (UMUC), The Ballrooms, 3501 University
Blvd. East, Adelphi, MD. The conference center telephone number is 301-
985-7300.
    Contact Person: Elaine Ferguson, e-mail:
<EMAIL_ADDRESS>(contact information through June 8, 2010,
Elaine Ferguson c/o Melanie Whelan, Food and Drug Administration, 10903
New Hampshire Ave., WO51-6100, Silver Spring, MD 20993-0002, telephone:
301-827-7001, FAX:<PHONE_NUMBER>), (contact information beginning June
9, 2010: Elaine Ferguson c/o Christine Shipe, Food and Drug
Administration, 10903 New Hampshire Ave., WO31-2419, Silver Spring, MD
20993-0002, telephone: 301-0796-9001, FAX:<PHONE_NUMBER>), or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), code<PHONE_NUMBER>. 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 about possible
modifications before coming to the meeting.
    Agenda: On September 14, 2010, the committee will discuss the abuse
potential of the drug dextromethorphan and the public health benefits
and risks of dextromethorphan use as a cough suppressant in
prescription and nonprescription drug products. The Department of
Health and Human Services received a request from the Drug Enforcement
Administration for a scientific and medical evaluation and scheduling
recommendation for dextromethorphan in response to the increased
incidence of abuse, especially among adolescents.
    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/AdvisoryCommittees/Calendar/
default.htm. 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 person on or before
August 30, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 20, 2010. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August
23, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the

agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Elaine Ferguson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 27, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-10384 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S