Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32483 

methodologic and regulatory issues 

related to the co-development of two or 

more investigational drugs intended to 

be used in combination. 

II. Issues on Which FDA is Seeking 

Comment 

All material submitted to this docket 

will be publicly available. To facilitate 

development of guidance that 

meaningfully addresses the concerns of 

those who may co-develop drugs 

intended to be used in combination, 

FDA is seeking input on the following 

issues, and any other issues relevant to 

developing FDA guidance: 

1. General methodologic and 

regulatory issues that arise in the codevelopment of two or more drugs 

intended to be used in combination 

where the drugs are directed at 

providing a therapeutic effect on the 

same symptom or manifestation of the 

disease or condition of interest, 

including relevance and utility of 

clinical or animal findings for either 

drug alone; 

2. General methodologic and 

regulatory issues that arise in the codevelopment of two or more drugs 

intended to be used in combination 

where the drugs are directed at 

providing a therapeutic effect for the 

same disease or condition, but act on 

different symptoms or manifestations of 

that disease or condition, including 

relevance and utility of clinical or 

animal findings for either drug alone; 

3. General methodologic and 

regulatory issues that arise in the codevelopment of two or more drugs 

intended to be used in combination 

where one or more of the drugs is 

intended to enhance the effectiveness of 

the other, but one or more of the drugs 

does not or may not have an 

independent therapeutic effect, 

including relevance and utility of 

clinical or animal findings for either 

drug alone; and 

4. Methodologic and regulatory issues 

that arise in the co-development of two 

or more drugs intended to be used in 

combination for specific therapeutic 

categories, including oncology, antiinfectives, seizure disorders, 

cardiovascular diseases, and any other 

therapeutic category in which such codevelopment is likely to occur. 

III. Submission of Comments 

Interested parties may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necesary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: June 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13769 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–0128] 

Prescription Drug User Fee Act; 

Meetings on Reauthorization; Request 

for Notification of Stakeholder 

Intention to Participate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for notification 

of participation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to request that public 

stakeholders—including patient and 

consumer advocacy groups, health care 

professionals, and scientific and 

academic experts—notify FDA of their 

intent to participate in periodic 

consultation meetings on 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA). The statutory 

authority for PDUFA expires in 

September 2012. At that time, new 

legislation will be required for FDA to 

continue collecting user fees for the 

prescription drug program. The Federal 

Food, Drug, and Cosmetic Act (the act) 

requires that FDA consult with a range 

of stakeholders in developing 

recommendations for the next PDUFA 

program. The act also requires that FDA 

hold continued discussions with patient 

and consumer advocacy groups at least 

monthly during FDA’s negotiations with 

the regulated industry. The purpose of 

this request for notification is to ensure 

continuity and progress in these 

discussions by establishing consistent 

stakeholder representation. 

DATES: Submit notification of intention 

to participate by June 25, 2010. The first 

stakeholder meeting will be held on July 

1, 2010, from 9 a.m. to 11 a.m. 

Stakeholder discussions will continue at 

least monthly during reauthorization 

negotiations with the regulated 

industry. 

ADDRESSES: Submit notification of 

intention to participate in monthly 

stakeholder meetings by e-mail to 

PDUFAReauthorization@fda.hhs.gov. 

The first stakeholder meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503C, Silver Spring, MD 20993. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Frey, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1174, 

Silver Spring, MD 20993, 301–796– 

3844, FAX: 301–847–8443. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The authority for PDUFA expires in 

September 2012. Without new 

legislation to reauthorize the program, 

FDA will no longer be able to collect 

user fees to fund the human drug review 

process. Section 736B(d)(1) (21 U.S.C. 

379h-2(d)(1)) of the act requires that 

FDA consult with a range of groups in 

developing recommendations for the 

next PDUFA program, including 

scientific and academic experts, health 

care professionals, and representatives 

from patient and consumer groups. FDA 

initiated this process of consultation on 

April 12, 2010, by holding a public 

meeting where stakeholders and other 

members of the public were given an 

opportunity to present their views on 

reauthorization (75 FR 12555, March 16, 

2010). This meeting and written 

comments submitted to the docket have 

provided critical input as the Agency 

prepares for reauthorization 

discussions. Section 736B(d)(3) of the 

act further requires that FDA continue 

meeting with these stakeholders at least 

once every month during negotiations 

with the regulated industry to continue 

discussions of their views on the 

reauthorization, including suggested 

changes to the PDUFA program. 

FDA is issuing this Federal Register 

notice to request that stakeholders— 

including patient and consumer 

advocacy groups, health care 

professionals, and scientific and 

academic experts—notify FDA of their 

intent to participate in periodic 

consultation meetings on 

reauthorization of PDUFA. FDA believes 

that consistent stakeholder 

representation at these meetings will be 

important to ensuring progress in these 

discussions. If you wish to participate in 

this part of the reauthorization process, 

please designate one or more 

representatives from your organization 

who will commit to attending these 

meetings and preparing for the 

discussions as needed. Stakeholders 

who identify themselves through this 

notice will be included in all future 

stakeholder discussions while FDA 


emcdonald on DSK2BSOYB1PROD with NOTICES
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