Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Health Resources and Services Administration

# AGENCY:

Health Resources and Services Administration (HRSA), HHS.

# ACTION:

Notice of noncompetitive program supplemental award.

# SUMMARY:

HRSA will be issuing non-competitive supplemental grant funding to the University of Wisconsin, Laboratory of Hygiene, Madison, Wisconsin, under the Maternal Child and Health Bureau's Blood Lead Proficiency Testing Program. The University of Wisconsin will use these funds to initiate an orderly closeout of HRSA-funded activities which clearly fall within the purview of the Centers for Disease Control and Prevention's “Preventing Lead Poisoning in Young Children” initiative at their National Center for Environmental Health. This action will also accord the University of Wisconsin and the Center additional time to solicit recommendations from the CDC's Advisory Committee on Childhood Lead Poisoning Prevention with respect to future funding for this activity.

                        The Maternal and Child Health Bureau (MCHB) has continuously supported the National Blood Lead and Erythrocyte Protoprophyrin (EP) Proficiency Testing Program through the University of Wisconsin since 1988. Childhood lead poisoning is a well-characterized public health problem in                               ( print page 160)                            the U.S., and is unfortunately over-represented in minority, immigrant, and low socio-economic populations. The proper detection and treatment of lead poisoning relies entirely on the accurate and precise measurement of blood lead concentration. EP is utilized as an adjunct test to indicate the extent and duration of lead exposure, as well as the detection of iron deficiency, another pediatric health issue. Proficiency testing (PT) is a proven method for assuring and improving laboratory test accuracy. This program has cost-effectively provided monthly PT and other lab quality improvement tools to nearly 600 laboratories across the U.S. and beyond. Of note, the primary focus of the program over the last few years has been the integration of new and usually inexperienced participants into the program. An enrollment boom has been fueled by proliferation of the CLIA-waived LeadCare II point of care testing instrument. In the three years since its introduction, LeadCare II enrollment has grown from zero to 300 laboratories, comprising approximately 40 percent of all participants. Continued participation increases, and the fact that those increases are nearly totally comprised of LeadCare II users, represent both a public health success and a challenge for this program. Since its introduction in early 2007, over 300 of these laboratories have enrolled for PT, swelling program participation to 800 laboratories.                    

# SUPPLEMENTARY INFORMATION:

*Intended Recipients of the Award:*                     University of Wisconsin, Laboratory of Hygiene, Madison, Wisconsin.                

*Amount of the Non-Competitive Supplemental Funding:*                     $250,000.                

Authority:Section 501(c)(1) of the Social Security Act, as amended.

*CFDA Number:*                     93.110.                

*Proposed Project Period:*                     January 1, 2008-October 31, 2011.                

*Justification for Exception to Competition:*

The participation of large numbers of these labs in voluntary proficiency was by design, and represents a public health success by assuring blood lead screening accuracy where there would otherwise be no evaluation. Three factors contribute to this. First, is the HRSA support of this program, which has been increased to accommodate the additional labs.

This support allows laboratories to participate at no cost, a vital consideration for voluntary participants. The second factor is the effort of the NBLPT Program to integrate the new technology shortly after it became available, and collaboration with the manufacturer to promote participation. The third factor is that some States have initiated PT requirements, deeming this quality check of sufficient importance to mandate successful participation as a requisite for Medicaid reimbursement. This State-level action illustrates the importance of this PT participation, and may be the beginning of a trend that will serve to increase participation even more.

The University of Wisconsin will use these funds to initiate an orderly closeout of HRSA-funded activities which clearly falls within the purview of the Centers for Disease Control and Prevention's “Preventing Lead Poisoning in Young Children” initiative at their National Center for Environmental Health. This extension with funding will also accord the University of Wisconsin and the Center to solicit recommendations from the CDC's Advisory Committee on Childhood Lead Poisoning Prevention with respect to future funding for this activity.

# FOR FURTHER INFORMATION CONTACT:

                        David Heppel, M.D., Director, Division of Child, Adolescent and Family Health, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18A-30, Rockville, MD 20857; 301-443-2250;                         *dheppel@hrsa.gov.*

Dated: December 23, 2010.

Mary K. Wakefield,

Administrator.

[FR Doc. 2010-33063 Filed 12-30-10; 8:45 am]

BILLING CODE 4165-15-P