27576 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1–

800–835–4709 or 301–827–1800. 

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: 

Rajeshwari Sridhara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 1210, 

Silver Spring, MD 20903–0002, 

301–796–2070; or 

Peter Bross, Center for Biologics 

Evaluation and Research (HFM–

755), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–5378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Clinical Trial Endpoints for the 

Approval of Cancer Drugs and 

Biologics.’’ FDA is developing guidance 

on oncology endpoints through a 

process that includes public workshops 

of oncology experts and discussions 

before FDA’s Oncologic Drugs Advisory 

Committee. This guidance provides 

background information and general 

principles. The endpoints discussed in 

this guidance are for drugs to treat 

patients with an existing cancer. This 

guidance does not address endpoints for 

drugs to prevent or decrease the 

incidence of cancer. 

The availability of a draft of this 

guidance was announced in the Federal 

Register of April 4, 2005 (70 FR 17095). 

Comments received from industry, 

professional societies, and consumer 

groups on the draft guidance have been 

taken into consideration by FDA in 

finalizing this guidance, and some of the 

changes are summarized here. The 

section on future methods for assessing 

progression has been clarified based on 

the comments received and FDA’s 

current thinking and practice. The 

section on no treatment or placebo 

control and the section on isolating drug 

effect in combination also have been 

clarified based on the comments 

received and FDA’s view that these do 

not directly concern the selection or 

evaluation of endpoints. Throughout the 

guidance document, the language has 

been condensed and simplified to be 

concise and clear. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on clinical trial 

endpoints for the approval of cancer 

drugs and biologics. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

21 CFR part 312 have been approved 

under 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001, and 

the collections of information referred to 

in the guidance for industry entitled 

‘‘Special Protocol Assessment’’ have 

been approved under 0910–0470. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. 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 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9345 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0185] 

Draft Guidance for Industry and 

Review Staff on Labeling for Human 

Prescription Drugs—Determining 

Established Pharmacologic Class for 

Use in the Highlights of Prescribing 

Information; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and review staff entitled 

‘‘Labeling for Human Prescription 

Drugs—Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’

This guidance is intended to help 

applicants and the review staff in the 

Center for Drug Evaluation and Research 

(CDER) at FDA determine when a drug 

belongs to an established pharmacologic 

class as well as how to select the 

appropriate word or phrase (term) that 

describes the pharmacologic class for 

inclusion in the Indications and Usage 

section of Highlights of Prescribing 

Information (Highlights) of approved 

labeling. 

DATES: Submit written or electronic 

comments on the draft guidance by 

August 14, 2007. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft 

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 draft 

guidance document. 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 27577 

1See ‘‘Requirements on Content and Format of 

Labeling for Human Prescription Drug and 

Biological Products’’ (71 FR 3922, January 24, 2006; 

21 CFR parts 201, 314, and 601). 

2See § 201.57(a)(6). 

FOR FURTHER INFORMATION CONTACT: 

William Pierce, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6474, 

Silver Spring, MD 20993–0002, 301–

796–0700. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and review 

staff entitled ‘‘Labeling for Human 

Prescription Drugs—Determining 

Established Pharmacologic Class for Use 

in the Highlights of Prescribing 

Information.’’ This guidance is intended 

to help applicants and CDER’s review 

staff determine when a drug belongs to 

an established pharmacologic class as 

well as how to select the appropriate 

word or phrase (term) that describes the 

pharmacologic class for inclusion in the 

Indications and Usage section of 

Highlights of Prescribing Information 

(Highlights) of approved labeling, as 

required by § 201.57(a)(6) (21 CFR 

201.57(a)(6)). 

In January 2006, FDA published a 

final rule that amended the 

requirements for the content and format 

of labeling for human prescription drug 

and biological products.1 The new 

labeling format is intended to make it 

easier for health care professionals to 

access, read, and use the information in 

prescription drug labeling, thereby 

facilitating professionals’ use of labeling 

to make prescribing decisions. 

The rule requires that the following 

statement appear under the Indications 

and Usage section of Highlights if a drug 

is a member of an established 

pharmacologic class:2

‘‘(Drug) is a (name of class) indicated 

for (indication(s)).’’

If the drug is not a member of an 

established pharmacologic class, the 

statement must be omitted. 

Knowing the established 

pharmacologic class can provide health 

care professionals with important 

information about what to expect from 

a drug and how it relates to other 

therapeutic options. Such information 

can also help reduce the risk of 

duplicative therapy and drug 

interactions. This draft guidance 

provides recommendations for 

identifying the established 

pharmacologic class and its appropriate 

term for inclusion in the Indications 

and Usage section of Highlights. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. 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 regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

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: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9347 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Tribal Management Grant Program 

Announcement Type: New and 

Competing Continuation Discretionary 

Funding Cycle for Fiscal Year 2008. 

Funding Announcement Number: 

HHS–2008–IHS–TMD–0001. 

Catalog of Federal Domestic 

Assistance Number(s): 93.228. 

Key Dates: Training: Application 

Requirements Session: May 8–9, May 

23–24, and June 13–14, 2007; Grant 

Writing Session: June 4–8, 2007. 

Application Deadline Date: August 3, 

2007. 

Receipt Date for Final Tribal 

Resolution: September 28, 2007. 

Review Date: October 1–5, 2007. 

Application Notification Date: 

November 12, 2007. 

Earliest Anticipated Start Date: 

January 1, 2008. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

announces competitive grant 

applications for the Tribal Management 

Grant (TMG) Program. This program is 

authorized under Section 103(b)(2) and 

Section 103(e) of the Indian SelfDetermination and Education 

Assistance Act, Pub. L. 93–638, as 

amended. This program is described at 

93.228 in the Catalog of Federal 

Domestic Assistance. 

The TMG Program is a national 

competitive discretionary grant program 

pursuant to 45 CFR 75 and 45 CFR 92 

established to assist Federallyrecognized Tribes and Triballysanctioned Tribal organizations in 

assuming all or part of existing IHS 

programs, services, functions, and 

activities (PSFA) through a Title I 

contract and to assist established Title I 

contractors and Title V compactors to 

further develop and improve their 

management capability. In addition, 

TMGs are available to Tribes/Tribal 

organizations under the authority of 

Public Law (Pub. L.) 93–638 section 

103(e) for (1) obtaining technical 

assistance from providers designated by 

the Tribe/Tribal organization (including 

Tribes/Tribal organizations that operate 

mature contracts) for the purposes of 

program planning and evaluation, 

including the development of any 

management systems necessary for 

contract management and the 

development of cost allocation plans for 

indirect cost rates; and (2) planning, 

designing and evaluating Federal health 

programs serving the Tribe/Tribal 

organization, including Federal 

administrative functions. 

Funding Priorities: The IHS has 

established the following funding 

priorities for TMG awards. 

• Priority 1—Any Indian Tribe that 

has received Federal recognition 

(restored, un-terminated, funded, or 

unfunded) within the past 5 years, 

specifically received during or after 

March 2002. 

• Priority II—All other eligible 

Federally-recognized Indian Tribes or 

Tribally-sanctioned Tribal organizations 

submitting a competing continuation 

application or a new application for the 

sole purpose of addressing audit 

material weaknesses. The audit material 

weaknesses are identified in Attachment 

A (Summary of Findings and 

Recommendations) and other 

attachments, if any, of the transmittal 

letter received from the Office of the 

Inspector General (OIG), National 

External Audit Review Center (NEARC), 

Department of Health and Human 

Services (HHS). Please identify the 


cprice-sewell on PROD1PC66 with NOTICES