Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability, 35450-35451 [2011-15089]

Download as PDF 35450 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Notices information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Total hours Documentation Submission ................................................. 1 1 1 3 3 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA expects the total number of pesticide tolerances that are revoked, suspended, or modified by EPA under dietary risk considerations in the next 3 years to remain at a low level, as there have been no changes to the safety standard for pesticide residues in food since 1996. Thus, FDA expects the number of submissions it will receive under the guidance document will also remain at a low level. However, to avoid counting this burden as zero, FDA has estimated the burden at one respondent making one submission a year for a total of one annual submission. FDA based its estimate of the hours per response on the assumption that the information requested in the guidance is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter’s company and to prepare this information for submission to FDA. The submitter will almost always merely need to copy existing documentation. We believe that this effort should take no longer than 3 hours per submission. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping (in hours) Total hours Maintenance of Documentation ........................................... 1 1 1 16 16 emcdonald on DSK2BSOYB1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In determining the estimated annual recordkeeping burden, FDA estimated that at least 90 percent of firms maintain documentation, such as packing codes, batch records, and inventory records, as part of their basic food production or import operations. Therefore, the recordkeeping burden was calculated as the time required for the 10 percent of firms that may not be currently maintaining this documentation to develop and maintain documentation, such as batch records and inventory records. In previous information collection requests, this recordkeeping burden was estimated to be 16 hours per record. FDA has retained its prior estimate of 16 hours per record for the recordkeeping burden. As shown in table 1, FDA estimates that one respondent will make one submission per year. Although FDA estimates that only 1 out of 10 firms will not be currently maintaining the necessary documentation, to avoid counting the recordkeeping burden for the 1 submission per year as 1/10 of a recordkeeper, FDA estimates that 1 recordkeeper will take 16 hours to develop and maintain documentation recommended by the guidance. VerDate Mar<15>2010 17:39 Jun 16, 2011 Jkt 223001 Dated: June 9, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15044 Filed 6–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0432] Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Clinical Trial Endpoints for the Approval of NonSmall Cell Lung Cancer Drugs and Biologics.’’ This draft guidance provides recommendations to applicants on endpoints for lung cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 applications. This draft guidance should speed the development and improve the quality of protocols submitted to the Agency to support anticancer effectiveness claims. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written E:\FR\FM\17JNN1.SGM 17JNN1 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Notices comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rajeshwari Sridhara, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3512, Silver Spring, MD 20903–0002, 301– 796–2070; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: emcdonald on DSK2BSOYB1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 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 (ODAC). This draft guidance considers the discussions regarding lung cancer endpoints from the April 15, 2003, workshop and the December 16, 2003, ODAC meeting. Applicants are encouraged to use this guidance to design clinical trials for the treatment of lung cancer and to discuss protocols with the Agency. This draft guidance is a companion to the guidance for industry entitled ‘‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics;’’ 1 it is the first in a series of oncology indication-specific guidances, and focuses on endpoints for lung cancer to support drug approval or labeling claims. The endpoints discussed in this draft guidance are for drugs to treat patients with lung cancer. This guidance does not address endpoints for drugs to prevent or decrease the incidence of lung cancer. 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 clinical trial endpoints for the approval of non-small cell lung 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 1 ‘‘See the FDA Drugs guidance Web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm.’’ VerDate Mar<15>2010 17:39 Jun 16, 2011 Jkt 223001 requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 parts 312, 314, and 601 have been approved under OMB control numbers 0910–0014, 0910–0001, and 0910–0338, respectively. 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 Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: June 8, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15089 Filed 6–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 35451 General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 14, 2011, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, e-mail: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Notices]
[Pages 35450-35451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15089]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0432]


Draft Guidance for Industry on Clinical Trial Endpoints for the 
Approval of Non-Small Cell Lung Cancer Drugs and Biologics; 
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 entitled ``Clinical Trial 
Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and 
Biologics.'' This draft guidance provides recommendations to applicants 
on endpoints for lung cancer clinical trials submitted to FDA to 
support effectiveness claims in new drug applications, biologics 
license applications, or supplemental applications. This draft guidance 
should speed the development and improve the quality of protocols 
submitted to the Agency to support anticancer effectiveness claims.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written

[[Page 35451]]

comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
Rajeshwari Sridhara, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3512, 
Silver Spring, MD 20903-0002, 301-796-2070;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell 
Lung 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 (ODAC). This draft guidance considers the discussions 
regarding lung cancer endpoints from the April 15, 2003, workshop and 
the December 16, 2003, ODAC meeting. Applicants are encouraged to use 
this guidance to design clinical trials for the treatment of lung 
cancer and to discuss protocols with the Agency. This draft guidance is 
a companion to the guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics;'' \1\ it is 
the first in a series of oncology indication-specific guidances, and 
focuses on endpoints for lung cancer to support drug approval or 
labeling claims. The endpoints discussed in this draft guidance are for 
drugs to treat patients with lung cancer. This guidance does not 
address endpoints for drugs to prevent or decrease the incidence of 
lung cancer.
---------------------------------------------------------------------------

    \1\ ``See the FDA Drugs guidance Web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
---------------------------------------------------------------------------

    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 clinical 
trial endpoints for the approval of non-small cell lung 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 that 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 parts 312, 314, and 601 
have been approved under OMB control numbers 0910-0014, 0910-0001, and 
0910-0338, respectively.

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

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: June 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15089 Filed 6-16-11; 8:45 am]
BILLING CODE 4160-01-P
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