International Conference on Harmonisation; Draft Guidance on E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions; Availability, 38033-38034 [E9-18227]

Download as PDF Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices that it deems necessary, including institution of proceedings to revoke any existing licenses held by the applicant. G. Refund of Remaining Upfront Payment Balance 186. After the auction, applicants that are not winning bidders or are winning bidders whose upfront payment exceeded the total net amount of their winning bids may be entitled to a refund of some or all of their upfront payment. All refunds will be returned to the payer of record, as identified on the FCC Form 159, unless the payor submits written authorization instructing otherwise. Bidders should not request a refund of their upfront payments before the Commission releases a public notice declaring the auction closed, identifying the winning bidders, and establishing the deadlines for submitting down payments, long-form applications, and final payments. Federal Communications Commission. Gary D. Michaels, Deputy Chief, Auctions and Spectrum Access Division, WTB. [FR Doc. E9–18198 Filed 7–29–09; 8:45 am] BILLING CODE 6712–01–P GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090–0044] Public Buildings Service; Submission for OMB Review; GSA Form 3453, Application/Permit for Use of Space in Public Buildings and Grounds Public Buildings Service, GSA. ACTION: Notice of request for comments regarding a renewal to an existing OMB clearance. erowe on DSK5CLS3C1PROD with NOTICES AGENCY: SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve a renewal of a currently approved information collection requirement regarding GSA Form 3453, Application/ Permit for Use of Space in Public Buildings and Grounds. A request for public comments was published at 74 FR 19094, April 27, 2009. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the VerDate Nov<24>2008 15:34 Jul 29, 2009 Jkt 217001 38033 quality, utility, and clarity of the information to be collected. DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: Submit comments on or before: August 31, 2009. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Frank Giblin, Public Buildings Service, at telephone (202) 501–1856, or via email to frank.giblin@gsa.gov. Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VPR), General Services Administration, 1800 F Street, NW., Room 4041, Washington, DC 20405. Please cite OMB Control No. 3090–0044, GSA Form 3453, Application/Permit for Use of Space in Public Buildings and Grounds, in all correspondence. ADDRESSES: SUPPLEMENTARY INFORMATION: A. Purpose The general public uses GSA Form 3453, Application/Permit for Use of Space in Public Buildings and Grounds, to request the use of public space in Federal buildings and on Federal grounds for cultural, educational, or recreational activities. A copy, sample, or description of any material or item proposed for distribution or display must also accompany this request. B. Annual Reporting Burden Respondents: 8,000. Responses per Respondent: 1. Hours per Response: 0.05. Total Burden Hours: 400. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0044, GSA Form 3453, Application/Permit for Use of Space in Public Buildings and Grounds, in all correspondence. Dated: July 21, 2009. Casey Coleman, Chief Information Officer. [FR Doc. E9–18129 Filed 7–29–09; 8:45 am] BILLING CODE 6820–34–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 [Docket No. FDA–2009–D–0324] International Conference on Harmonisation; Draft Guidance on E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. 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 written or electronic comments on the draft guidance by September 28, 2009. 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 the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. Send two self-addressed adhesive labels to assist the 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 https:// E:\FR\FM\30JYN1.SGM 30JYN1 38034 Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Federico Goodsaid, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2148, Silver Spring, MD 20903–0002, 301–796–1535; or Jennifer Catalano, Center for Biologics Evaluation and Research (HFM–735), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–0706. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4480. SUPPLEMENTARY INFORMATION: erowe on DSK5CLS3C1PROD with NOTICES I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International VerDate Nov<24>2008 15:34 Jul 29, 2009 Jkt 217001 Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In June 2009, the ICH Steering Committee agreed that a draft guidance entitled ‘‘E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions’’ should be made available for public comment. The draft guidance is the product of the E16 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the E16 Expert Working Group. The use of biomarkers in drug discovery, development, and postapproval has the potential to facilitate development of safer and more effective medicines, to guide dose selection, and to enhance the benefitrisk profile of approved medicines. This draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. To support the evaluation of genomic biomarkers, the draft guidance describes and defines a submission standard applicable across regions. The recommendations are based on previous experiences in the various regions with submissions containing genomic biomarker data. Such submissions have been either stand-alone biomarker qualification applications or a component of medicinal product-related regulatory process. Where appropriate, the proposed document format is expected to facilitate incorporation of genomic biomarker data into specific productrelated applications. 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 on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 https:// www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: July 23, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–18227 Filed 7–29–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Family-To-Family Health Information Center Program AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of noncompetitive replacement award to Colorado NonProfit Development Center. SUMMARY: The Health Resources and Services Administration (HRSA) will be transferring Family Voices Colorado Family-To-Family Health Information Center (F2F HIC) grant (H84 MC 09577) from Cerebral Palsy of Colorado to the Colorado Non-Profit Development Center in Denver in order to ensure the continued provision of health resources, financing, related services and parentto-parent support for families with children and youth with special health care needs in the State of Colorado. SUPPLEMENTARY INFORMATION: Former Grantee of Record: Cerebral Palsy of Colorado. Original Period of Grant Support: June 1, 2008, to May 31, 2011. Replacement awardee: Colorado NonProfit Development Center. Amount of Replacement Award: $153,572 for year 2 and $95,700 for year 3 of the remaining project period. Period of Replacement Award: The period of support for the replacement award is July 1, 2009, to May 31, 2011. Authority: Section 501(c)(1)(A) of the Social Security Act. E:\FR\FM\30JYN1.SGM 30JYN1

Agencies

[Federal Register Volume 74, Number 145 (Thursday, July 30, 2009)]
[Notices]
[Pages 38033-38034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0324]


International Conference on Harmonisation; Draft Guidance on E16 
Genomic Biomarkers Related to Drug Response: Context, Structure, and 
Format of Qualification Submissions; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``E16 Genomic Biomarkers 
Related to Drug Response: Context, Structure, and Format of 
Qualification Submissions.'' The draft guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The draft guidance describes recommendations regarding context, 
structure, and format of regulatory submissions for qualification of 
genomic biomarkers. The draft guidance is intended to foster 
consistency of applications across regions and facilitate joint 
discussions with and among regulatory authorities.

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 written or electronic comments on the draft guidance 
by September 28, 2009.

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 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800. Send two self-addressed adhesive labels to assist the 
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 https://

[[Page 38034]]

www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Federico Goodsaid, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2148, Silver Spring, MD 20903-0002, 301-
796-1535; or Jennifer Catalano, Center for Biologics Evaluation and 
Research (HFM-735), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-0706.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2009, the ICH Steering Committee agreed that a draft 
guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: 
Context, Structure, and Format of Qualification Submissions'' should be 
made available for public comment. The draft guidance is the product of 
the E16 Expert Working Group of the ICH. Comments about this draft will 
be considered by FDA and the E16 Expert Working Group.
    The use of biomarkers in drug discovery, development, and 
postapproval has the potential to facilitate development of safer and 
more effective medicines, to guide dose selection, and to enhance the 
benefit-risk profile of approved medicines. This draft guidance 
describes recommendations regarding context, structure, and format of 
regulatory submissions for qualification of genomic biomarkers. To 
support the evaluation of genomic biomarkers, the draft guidance 
describes and defines a submission standard applicable across regions. 
The recommendations are based on previous experiences in the various 
regions with submissions containing genomic biomarker data. Such 
submissions have been either stand-alone biomarker qualification 
applications or a component of medicinal product-related regulatory 
process. Where appropriate, the proposed document format is expected to 
facilitate incorporation of genomic biomarker data into specific 
product-related applications.
    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 on the draft guidance. 
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 
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: July 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18227 Filed 7-29-09; 8:45 am]
BILLING CODE 4160-01-S

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