Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 9951 

response to PAR 06–057, ‘‘Agricultural 

Center Review.’’

For Further Information Contact: Stephen 

Olenchock, Scientific Review Administrator, 

1095 Willowdale Road, Morgantown, WV 

26506, telephone (304) 285–6271. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–3852 Filed 3–5–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2001D–0432] 

Guidance for Industry on Orally 

Inhaled and Intranasal Corticosteroids: 

Evaluation of the Effects on Growth in 

Children; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Orally Inhaled and Intranasal 

Corticosteroids: Evaluation of the Effects 

on Growth in Children.’’ This guidance 

provides recommendations regarding 

the design, conduct, and evaluation of 

clinical trials to assess the effects of 

orally inhaled and intranasal 

corticosteroids on growth in children. 

For this class of drug products, 

measurement of growth is considered a 

sensitive surrogate of, and an important 

sentinel for, the potential to cause 

systemic effects. Growth studies 

designed and carried out following the 

recommendations in this guidance can 

provide adequate and well-controlled 

data that are consistent among drug 

products and can be included in 

product labeling. This guidance 

finalizes the draft guidance published 

on November 6, 2001. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Peter Starke, Center for Drug Evaluation 

and Research (HFD–7), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 3300, Silver Spring, 

MD 20993–0002, 301–796–2300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Orally 

Inhaled and Intranasal Corticosteroids: 

Evaluation of the Effects on Growth in 

Children.’’ This guidance provides 

recommendations for the design, 

conduct, and evaluation of clinical 

studies to assess the effects of orally 

inhaled and intranasal corticosteroids 

on linear growth (‘‘growth study’’). The 

guidance was developed by the Division 

of Pulmonary and Allergy Products in 

consultation with the Division of 

Metabolism and Endocrinology 

Products and the Office of Biostatistics 

to encourage the collection of evidence 

that can consistently and accurately 

describe the effects of intranasal and 

orally inhaled corticosteroids on growth 

velocity in children. 

In July 1998, the Pulmonary and 

Allergy Drugs Advisory Committee and 

the Metabolic and Endocrine Drugs 

Advisory Committee were jointly 

convened to discuss the implications of 

findings in previous clinical studies that 

indicated that inhaled corticosteroids 

can, as a class of drug products, affect 

linear growth in pediatric patients. The 

joint committee concluded that data 

were sufficient to justify inclusion of a 

precautionary statement in the labeling 

for this class of drug products, but the 

data were inadequate to precisely 

determine the decrement in growth 

velocity resulting from the use of these 

drug products. Members of the joint 

committee recommended that 

companies filing new drug applications 

for all newly approved corticosteroid 

products conduct further studies, as 

post-approval phase 4 commitments, to 

assess the effects of nasally and orally 

inhaled corticosteroids on growth 

velocity in prepubertal children. On 

November 6, 2001 (66 FR 56109), FDA 

published for comment in the Federal 

Register a draft of this guidance. 

Comments received from industry, 

professional societies, and consumer 

groups on the draft guidance have been 

taken into consideration in finalizing 

this guidance. Changes are based on 

thorough review of all comments 

received, growth studies submitted 

since publication of the draft guidance, 

and previously submitted growth data. 

Changes or updates were made to all 

sections of the guidance, and are briefly 

summarized here. 

A new overview section and updated 

background and data analysis sections 

include a more thorough discussion of 

the objective of and the appropriate 

statistical comparisons for a growth 

study. These changes will affect future 

labeling for such studies. 

Recommendations for sample size 

calculations and primary and secondary 

‘‘sensitivity’’ analyses have been 

reviewed and modified based on review 

of growth studies submitted since 

publication of the draft guidance as well 

as previously submitted data. The 

general study recommendations and 

protocol design sections include a 

discussion of the appropriate patient 

populations to be studied and 

modifications to recommendations for 

the inclusion and exclusion criteria, 

assessments of adherence, and spacer 

use. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on the 

evaluation of the effects of orally 

inhaled and intranasal corticosteroids 

on growth in children. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Submit 

a single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 


cprice-sewell on PROD1PC67 with NOTICES
9952 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: February 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3807 Filed 3–5–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http://workplace.samhsa.gov 

and http://www.drugfreeworkplace.gov. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh or Dr. Walter Vogl, 

Division of Workplace Programs, 

SAMHSA/CSAP, Room 2–1035, 1 Choke 

Cherry Road, Rockville, Maryland 

20857; 240–276–2600 (voice), 240–276–

2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Pub. L. 100–

71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 

validity tests on urine specimens for 

Federal agencies. To become certified, 

an applicant laboratory must undergo 

three rounds of performance testing plus 

an on-site inspection. To maintain that 

certification, a laboratory must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories which claim to be in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A laboratory 

must have its letter of certification from 

HHS/SAMHSA (formerly: HHS/NIDA) 

which attests that it has met minimum 

standards. 

In accordance with Subpart C of the 

Mandatory Guidelines dated April 13, 

2004 (69 FR 19644), the following 

laboratories meet the minimum 

standards to conduct drug and specimen 

validity tests on urine specimens: 

ACL Laboratories, 8901 W. Lincoln 

Ave., West Allis, WI 53227, 414–328–

7840 / 800–877–7016 (Formerly: 

Bayshore Clinical Laboratory) 

ACM Medical Laboratory, Inc., 160 

Elmgrove Park, Rochester, NY 14624, 

585–429–2264. 

Advanced Toxicology Network, 3560 

Air Center Cove, Suite 101, Memphis, 

TN 38118, 901–794–5770 / 888–290–

1150. 

Aegis Analytical Laboratories, Inc., 345 

Hill Ave., Nashville, TN 37210, 615–

255–2400. 

Baptist Medical Center—Toxicology 

Laboratory, 9601 I–630, Exit 7, Little 

Rock, AR 72205–7299, 501–202–2783 

(Formerly: Forensic Toxicology 

Laboratory Baptist Medical Center) 

Clinical Reference Lab, 8433 Quivira 

Road, Lenexa, KS 66215–2802, 800–

445–6917. 

Diagnostic Services, Inc., dba DSI, 

12700 Westlinks Drive, Fort Myers, 

FL 33913, 239–561–8200 / 800–735–

5416. 

Doctors Laboratory, Inc., 2906 Julia 

Drive, Valdosta, GA 31602, 229–671–

2281. 

DrugScan, Inc., P.O. Box 2969, 1119 

Mearns Road, Warminster, PA 18974, 

215–674–9310. 

Dynacare Kasper Medical Laboratories,* 

10150–102 St., Suite 200, Edmonton, 

Alberta, Canada T5J 5E2, 780–451–

3702 / 800–661–9876. 

ElSohly Laboratories, Inc., 5 Industrial 

Park Drive, Oxford, MS 38655, 662–

236–2609. 

Gamma-Dynacare Medical 

Laboratories,* A Division of the 

Gamma-Dynacare Laboratory 

Partnership, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519–

679–1630. 

Kroll Laboratory Specialists, Inc., 1111 

Newton St., Gretna, LA 70053, 504–

361–8989/800–433–3823 (Formerly: 

Laboratory Specialists, Inc.) 

Kroll Scientific Testing Laboratories, 

Inc., 450 Southlake Blvd., Richmond, 

VA 23236, 804–378–9130 (Formerly: 

Scientific Testing Laboratories, Inc.) 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Road, 

Houston, TX 77040, 713–856–8288/ 

800–800–2387. 

Laboratory Corporation of America 

Holdings, 69 First Ave., Raritan, NJ 

08869, 908–526–2400/800–437–4986 

(Formerly: Roche Biomedical 

Laboratories, Inc.) 

Laboratory Corporation of America 

Holdings, 1904 Alexander Drive, 

Research Triangle Park, NC 27709, 

919–572–6900/800–833–3984 

(Formerly: LabCorp Occupational 

Testing Services, Inc., CompuChem 

Laboratories, Inc.; CompuChem 

Laboratories, Inc., A Subsidiary of 

Roche Biomedical Laboratory; Roche, 

CompuChem Laboratories, Inc., A 

Member of the Roche Group) 

Laboratory Corporation of America 

Holdings, 10788 Roselle St., San 

Diego, CA 92121, 800–882–7272 

(Formerly: Poisonlab, Inc) 

Laboratory Corporation of America 

Holdings, 550 17th Ave., Suite 300, 

Seattle, WA 98122, 206–923–7020/ 

800–898–0180 (Formerly: DrugProof, 

Division of Dynacare/Laboratory of 

Pathology, LLC; Laboratory of, 

Pathology of Seattle, Inc.; DrugProof, 

Division of Laboratory of Pathology of 

Seattle, Inc.) 

Laboratory Corporation of America 

Holdings, 1120 Main Street, 

Southaven, MS 38671, 866–827–8042/ 

800–233–6339 (Formerly: LabCorp 

Occupational Testing Services, Inc.; 

MedExpress/National Laboratory 

Center) 

LabOne, Inc. d/b/a Quest Diagnostics, 

10101 Renner Blvd., Lenexa, KS 

66219, 913–888–3927/800–873–8845 

(Formerly: Quest Diagnostics 

Incorporated; LabOne, Inc.; Center for 

Laboratory Services, a Division of 

LabOne, Inc.) 

Marshfield Laboratories, Forensic 

Toxicology Laboratory, 1000 North 

Oak Ave., Marshfield, WI 54449, 715–

389–3734/800–331–3734. 


cprice-sewell on PROD1PC67 with NOTICES