Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32485 

development of deoxyribonucleic acid 

(DNA) array methodologies, such as 

microarray-based comparative genomic 

hybridization (aCGH) and singlenucleotide polymorphism (SNP) arrays 

allow a high-resolution evaluation of 

DNA copy number alterations 

associated with chromosome 

abnormalities. Array-based cytogenetic 

testing is currently being implemented 

in the clinical setting as a method for 

detecting pathological genomic copy 

number changes. 

FDA regulation and review of in vitro 

diagnostic devices has traditionally 

been a single marker-based, indicationspecific process that ensures safety and 

effectiveness of the product. However, 

the results obtained from array-based 

cytogenetic tests are not necessarily 

predefined and may not be associated 

with known clinical syndromes. 

Evaluating complex devices such as 

array-based cytogenetic tests challenges 

the traditional method of FDA review. 

II. Meeting Overview 

During the meeting, FDA staff will 

present a brief background and 

overview of in vitro diagnostic (IVD) 

regulation. Specific questions related to 

review challenges for array-based 

cytogenetic tests are listed in section III 

of this document, Topics for Input. After 

the open comment session, the meeting 

will close with a round-table discussion 

between FDA staff and selected 

participants representing a range of 

constituencies. The participants in the 

round-table discussion will engage in a 

dialogue on discussion topics (see 

section III of this document), and 

provide closing thoughts. The 

participants will not be asked to 

develop consensus opinions during the 

discussion, but rather to provide their 

individual perspectives. Others in 

attendance at the meeting will have an 

opportunity to listen to the round-table 

discussion. 

In advance of the meeting, additional 

information, including a meeting 

agenda, will be made available on the 

Internet. This information will be 

placed on file in the public docket 

(docket number found in brackets in the 

heading of this document), which is 

available at http://www.regulations.gov. 

This information will also be available 

at http://www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select the appropriate 

meeting from the list). 

III. Topics for Input 

FDA seeks input on the following 

issues: 

1. Clinical significance 

a. The resolution of array-based 

cytogenetic tests and the presence of 

copy number variations (CNVs) in the 

apparently healthy population poses 

challenges for result interpretation. 

What criteria should be used to 

determine the clinical significance of 

CNVs (e.g., when categorized as benign, 

pathogenic, or of unknown 

significance)? 

b. Should there be different 

requirements implemented for 

interpreting the clinical significance of 

deletions vs. duplications vs. 

translocations? 

2. Result reporting and interpretation 

a. Should result output be limited to 

results associated with known 

syndromes that can be adequately 

validated clinically and analytically? 

b. What criteria (e.g., minimum 

overlap, size, etc.) should be used to 

conclude findings are indicative of 

known syndrome? 

c. Should the performing, ordering 

and/or result interpretation of these 

tests be limited to certain professionals 

(e.g., clinical cytogeneticists)? 

d. How does FDA ensure that the 

results are interpreted correctly? 

3. Additional and confirmatory testing 

a. Should any array-based cytogenetic 

testing of an affected individual include 

testing of parents where possible? 

b. Should a second followup test (e.g., 

FISH) be required for result 

confirmation prior to reporting arraybased cytogenetic results? 

4. Incidental findings 

Laboratories are obliged to report 

clinically significant findings unrelated 

to the test order, when identified. How 

can the reporting of results for diseases 

or conditions outside of the indications 

for use be restricted? 

5. Clinical evaluation for approval of 

array-based cytogenetic devices 

a. Would validation of a group of 

CNVs associated with well-known 

syndromes be acceptable as a 

representation of all types of detectable 

CNVs? 

b. If yes, then which syndromes 

should be included and how many 

CNVs would be a representative 

number? 

c. What should be used as the 

reference genome? 

d. What studies should be performed 

to understand clinical specificity? 

6. Use of database(s) in result 

reporting 

a. How can the accuracy of 

information used in the determination 

of results be assured? 

i. Who should develop and maintain 

a curated database of known/probable 

CNV changes and benign findings in the 

population? 

ii. FDA regulations require that all 

aspects of a test involved in result 

output are under design controls in 

accordance with the Quality System 

regulations. When implementing the 

database for result reporting, how can it 

be assured that the database is 

adequately maintained and meets 

appropriate quality standards? 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: June 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13768 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Planning Centers for 

Interdisciplinary Research in Benign Urology 

(IR–BU) (P20). 

Date: July 9, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Wardman Park Washington, 

DC Hotel, 2660 Woodley Road, NW., 

Washington, DC 20008. 


emcdonald on DSK2BSOYB1PROD with NOTICES
32486 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

Contact Person: Paul A. Rushing, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 747, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8895, 

rushingp@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK Hematology 

Center Application Review. 

Date: July 26–27, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Xiaodu Guo, MD, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 761, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–4719, 

guox@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Program Projects in 

IBD. 

Date: July 26, 2010. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Maria E. Davila-Bloom, 

PhD, Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 758, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7637, davilabloomm@extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: June 2, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13734 Filed 6–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

National Cooperative Drug Discovery and 

Development Groups. 

Date: July 16, 2010. 

Time: 9 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of 

Health,Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Vinod Charles, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6151, MSC 9606, 

Bethesda, MD 20892–9606, 301–443–1606, 

charlesvi@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: June 1, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13726 Filed 6–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NINR HIV RFA Review Meeting. 

Date: July 8, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Mario Rinaudo, MD, 

Scientific Review Administrator, Office of 

Review, National Institute of Nursing 

Research, National Institutes of Health, 6701 

Democracy Blvd (DEM 1), Suite 710, 

Bethesda, MD 20892, 301–594–5973, 

mrinaudo@mail.nih.gov. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NINR End of Life RFA Review Meeting. 

Date: July 15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Tamizchelvi Thyagarajan, 

PhD, Scientific Review Officer, National 

Institute of Nursing Research, National 

Institutes of Health, 6701 Democracy Blvd, 

Rm 710, Bethesda, MD 20892, (301) 594– 

0343, tamizchelvi.thyagarajan@nih.gov. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NINR Epigenetic RFA Review Meeting. 

Date: July 19, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Tamizchelvi Thyagarajan, 

PhD, Scientific Review Officer, National 

Institute of Nursing Research, National 

Institutes of Health, 6701 Democracy Blvd, 

Rm 710, Bethesda, MD 20892, (301) 594– 

0343, tamizchelvi.thyagarajan@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: May 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13712 Filed 6–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors for Basic 

Sciences National Cancer Institute. 


emcdonald on DSK2BSOYB1PROD with NOTICES