32484 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

negotiates with the regulated industry. If 

a stakeholder decides to participate in 

these monthly meetings at a later time, 

they may still participate in remaining 

monthly meetings by notifying FDA (see 

ADDRESSES). These stakeholder 

discussions will satisfy the requirement 

in section 736B(d)(3) of the act. 

II. Additional Information on PDUFA 

There are several sources of 

information on FDA’s Web site that may 

serve as useful resources for 

stakeholders participating in the 

periodic consultation meetings: 

• Information on the April 2010 

public meeting on PDUFA 

Reauthorization, the Federal Register 

notice announcing the meeting, and the 

transcript of the meeting are available at 

http://www.fda.gov/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

ucm117890.htm. The slide 

presentations from the meeting can be 

found at http://www.regulations.gov 

using Docket No. FDA–2010–N–0128. 

• FDA created a webinar on the 

PDUFA program, drug development, 

and FDA’s drug review in PDUFA IV. 

These presentations are available at 

http://www.fda.gov/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

ucm207597.htm. 

• Key Federal Register documents, 

PDUFA-related guidances, legislation, 

performance reports, and financial 

reports and plans are posted at http:// 

www.fda.gov/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/default.htm. 

• The Food and Drug Administration 

Amendments Act of 2007 (FDAAA)- 

specific information is available at: 

http://www.fda.gov/Regulatory

Information/Legislation/ 

FederalFoodDrugandCosmeticAct

FDCAct/SignificantAmendmentstothe

FDCAct/FoodandDrugAdministration

AmendmentsActof2007/default.htm 

III. Notification of Intent to Participate 

in Periodic Consultation Meetings 

If you intend to participate in 

continued periodic stakeholder 

consultation meetings regarding PDUFA 

Reauthorization, please provide 

notification by e-mail to 

PDUFAReauthorization@fda.hhs.gov by 

June 25, 2010. Your e-mail should 

contain complete contact information, 

including name, title, affiliation, 

address, e-mail address, phone number, 

and notice of any special 

accommodations required because of 

disability. Stakeholders will receive 

confirmation and additional information 

about the first meeting once FDA 

receives their notification. 

Dated: June 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13671 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0259] 

Array-Based Cytogenetic Tests: 

Questions on Performance Evaluation, 

Result Reporting and Interpretation; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public meeting: Array-Based 

Cytogenetic Tests: Questions on 

Performance Evaluation, Result 

Reporting and Interpretation. The 

purpose of the public meeting is to seek 

input on challenges related to 

performance evaluation, determination 

of clinical significance, result reporting, 

and interpretation for array-based 

cytogenetic tests. 

Date and Time: The meeting will be 

held on June 30, 2010, from 1:30 p.m. 

to 5 p.m. 

Location: The meeting will be held at 

Hyatt Regency Bethesda, 7400 

Wisconsin Ave., 1 Bethesda Metro 

Center, Bethesda, MD. 

Contact: Susan Monahan, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4321, 

Silver Spring, MD 20903, 301–796– 

5661, e-mail: 

Susan.Monahan@fda.hhs.gov; or Zivana 

Tezak, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 5668, Silver Spring, MD 20903, 

301–796–6206, e-mail: 

Zivana.Tezak@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), and written material and 

requests to make oral presentations, to 

the contact person by June 21, 2010. 

Registration is free and will be on a firstcome, first-served basis. Early 

registration is recommended because 

seating is limited. FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the public 

meeting will be provided on a spaceavailable basis beginning at 7 a.m. 

If you wish to make an oral 

presentation during the open comment 

session at the meeting, you must 

indicate this at the time of registration. 

FDA has included general discussion 

topics and specific questions for 

comment in section III of this document, 

Topics for Input. You should also 

identify which discussion topic you 

wish to address in your presentation. 

FDA will do its best to accommodate 

requests to speak. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan or Zivana Tezak (see Contact) 

at least 7 days in advance. 

Comments: FDA is holding this public 

meeting to obtain input on a number of 

questions regarding review and 

interpretation issues for array-based 

cytogenetic testing. 

Regardless of attendance at the 

meeting, interested persons may submit 

either electronic or written comments 

on any discussion topic(s) to the open 

docket. The deadline for submitting 

comments to the docket is July 30, 2010. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section III of this 

document, please identify the question 

you are addressing. Received comments 

may be seen in the Division of Dockets 

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

Monday through Friday. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Many human genetic disorders are a 

result of the gain or loss of human 

genetic material, which may manifest as 

congenital anomalies, dysmorphic 

features, developmental disabilities, etc. 

Traditionally, chromosomes were 

analyzed using a method called 

karyotyping. In addition, molecular 

methods such as fluorescence in situ 

hybridization (FISH) provide the 

information about chromosome 

abnormalities at specific loci. The recent 


emcdonald on DSK2BSOYB1PROD with NOTICES
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