32482 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

domestic commerce unless its packaging 

complies with section 3 of the 

Smokeless Tobacco Act (Id.). Among the 

requirements in section 3(b)(3) is that 

the rotation of label statements on 

packaging and advertising for each 

brand of smokeless tobacco must be ‘‘in 

accordance with a plan submitted by the 

tobacco product manufacturer, importer, 

distributor, or retailer’’ to, and approved 

by, FDA (Id.). 

At this time, as an exercise of 

enforcement discretion, FDA does not 

intend to commence or recommend 

enforcement of the requirement that a 

smokeless tobacco manufacturer, 

distributor, importer, or retailer must 

have an FDA-approved rotational 

warning plan, so long as a rotational 

warning plan has been submitted to 

FDA by July 22, 2010. FDA believes that 

allowing additional time for the review 

of rotational warning plans will permit 

an orderly transition of regulatory 

authority from FTC to FDA to review 

and approve rotational warning plans. 

During such transition between June 22, 

2010, and July 22, 2010, affected 

companies may wish to contact FDA to 

discuss the submission of their 

rotational warning plans in order to 

make the subsequent approval process 

more orderly and efficient. FDA intends 

to provide further public notice prior to 

revising or rescinding this enforcement 

policy after the transition from FTC to 

FDA has been accomplished for the 

submission and review of rotational 

warning plans. This enforcement policy 

pertains only to the requirement that 

smokeless tobacco manufacturers, 

distributors, importers, or retailers must 

have an FDA-approved rotational 

warning plan. FDA expects compliance 

with regard to all other requirements of 

section 3 of the Smokeless Tobacco Act, 

including the requirements relating to 

size, formatting, location, and use of 

required warning statements. 

II. Significance of Guidance 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulations (21 CFR 10.115). 

This guidance is being implemented 

immediately without prior public 

comment under 10.115(g)(2) because the 

agency has determined that prior public 

participation is not feasible or 

appropriate. This document provides 

guidance on statutory provisions that 

take effect June 22, 2010. It is important 

that FDA explain its enforcement policy 

concerning the submission and approval 

of rotational warning plans for 

smokeless tobacco products before that 

date. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary 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. 

IV. Electronic Access 

An electronic version of this guidance 

document is available on the Internet at 

http://www.regulations.gov and http:// 

www.fda.gov/TobaccoProducts/ 

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: June 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13819 Filed 6–4–10; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0247] 

Investigational New Drug Applications; 

Co-development of Investigational 

Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of docket; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

public docket to obtain input on 

methods to co-develop two or more 

distinct investigational drugs intended 

to be used in combination to treat a 

disease or condition. FDA is planning to 

develop guidance for industry and other 

affected parties on the co-development 

of two or more novel drugs intended to 

be used in combination (but not as not 

fixed-dose combinations) and is seeking 

public input to identify the affected 

parties’ information needs concerning 

such co-development. Accordingly, 

FDA is seeking comment on general 

methodologic and regulatory issues that 

arise in various scenarios when codeveloping two or more investigational 

drugs intended to be used in 

combination. FDA is also seeking 

comment on methodologic and 

regulatory issues when co-developing 

two or more investigational drugs 

intended to be used in combination for 

specific therapeutic areas, including 

oncology, anti-infectives, seizure 

disorders, cardiovascular diseases, and 

any other therapeutic category in which 

such co-development is likely to occur. 

DATES: Submit either electronic or 

written comments by September 7, 

2010. 

ADDRESSES: Submit written comments 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Colleen L. Locicero, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4200, 

Silver Spring, MD 20993–0002, 301– 

796–2270. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is aware of growing interest in 

co-developing two or more distinct, 

novel investigational drugs intended to 

be used in combination to treat a disease 

or condition (but not as fixed-dose 

combinations under 21 CFR 300.50). At 

a September 2009 conference co-hosted 

by the ‘‘Friends of Cancer Research’’ in 

partnership with the Engelberg Center 

for Health Care Reform at the Brookings 

Institution, and supported by the 

American Society for Clinical Oncology 

(ASCO), the American Association for 

Cancer Research (AACR) Susan G. 

Komen for the Cure, and the Lance 

Armstrong Foundation (Brookings 

Conference), which was attended by 

FDA scientists, there was considerable 

interest in approaches to developing 

new oncology therapies intended to be 

used in combination. In addition, on 

April 30, 2010, FDA held a public 

hearing in accordance with part 15 (21 

CFR part 15) devoted, in part, to 

obtaining information about study 

designs and appropriate populations for 

developing two or more novel, directacting antivirals intended to be used in 

combination for the treatment of chronic 

hepatitis C. FDA is also aware of efforts 

to try to develop two or more 

investigational drugs intended to be 

used in combination to treat 

tuberculosis. FDA is further aware of 

general uncertainty about the 

evidentiary requirements and regulatory 

criteria applicable to such codevelopment efforts. Accordingly, FDA 

is planning to develop generally 

applicable guidance (not restricted to 

oncology or any other specific 

therapeutic category) to address 


emcdonald on DSK2BSOYB1PROD with NOTICES
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