Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability, 42346 [05-14456]

Download as PDF 42346 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices Notice of this meeting is given under the Federal Advisory committee Act (5 U.S.C. app. 2). Dated: July 18, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14455 Filed 7–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D–0492] (formerly Docket No. 02D–0492) Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.’’ This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 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:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Lois M. Freed, Center for Drug Evaluation and Research (HFD–120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2647. SUPPLEMENTARY INFORMATION: SUMMARY: VerDate jul<14>2003 19:28 Jul 21, 2005 Jkt 205001 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.’’ This guidance provides a description and basis for a process by which to select an MRSD for a first-inhuman clinical trial of a new molecular entity in adult healthy volunteers. In the Federal Register of January 16, 2003 (68 FR 2340), FDA published a notice making available a draft guidance entitled ‘‘Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers.’’ The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of this guidance were reworded to improve clarity. The guidance outlines a recommended standardized approach (including common conversion factors for calculating human equivalent doses) and vocabulary for selecting an MRSD based on animal data, and discusses factors to be considered in determining reasonable safety margins. This approach is applicable to a first-inhuman trial of a new drug or biological therapeutic, regardless of intended clinical use. The guidance also discusses alternative approaches and provides some examples of circumstances under which alternative approaches for selection of an MRSD should be considered. Dose escalation is not addressed. 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 estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. 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 guidance at any time. 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. The guidance and received comments are available for public examination in the Division of PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/ohrms/dockets/ default.htm. Dated: July 14, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14456 Filed 7–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The National Health Service Corps Uniform Data System (OMB No. 0915–0232): Revision The National Health Service Corps (NHSC) of the Bureau of Health Professions (BHPr), Health Resources and Services Administration (HRSA), is committed to improving the health of the Nation’s underserved by uniting communities in need with caring health professionals and by supporting communities’ efforts to build better systems of care. The NHSC needs to collect data on its programs to ensure compliance with legislative mandates and to report to Congress and policymakers on program accomplishments. To meet these objectives, the NHSC requires a core set of information collected annually that is appropriate for monitoring and evaluating performance and reporting on annual trends. The following information will be collected from each site: services offered and delivery method; users by various characteristics; staffing and utilization; charges and E:\FR\FM\22JYN1.SGM 22JYN1

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[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Page 42346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0492] (formerly Docket No. 02D-0492)


Guidance for Industry on Estimating the Maximum Safe Starting 
Dose in Initial Clinical Trials for Therapeutics in Adult Healthy 
Volunteers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Estimating the 
Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics 
in Adult Healthy Volunteers.'' This guidance provides a description and 
basis for a process by which to select a maximum recommended starting 
dose (MRSD) for a first-in-human clinical trial of a therapeutic in 
adult healthy volunteers.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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 self-addressed adhesive label to 
assist that office in processing your requests. 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 https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lois M. Freed, Center for Drug 
Evaluation and Research (HFD-120), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2647.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Estimating the Maximum Safe Starting Dose in Initial 
Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This 
guidance provides a description and basis for a process by which to 
select an MRSD for a first-in-human clinical trial of a new molecular 
entity in adult healthy volunteers. In the Federal Register of January 
16, 2003 (68 FR 2340), FDA published a notice making available a draft 
guidance entitled ``Estimating the Safe Starting Dose in Clinical 
Trials for Therapeutics in Adult Healthy Volunteers.'' The notice gave 
interested persons an opportunity to submit comments. As a result of 
the comments, certain sections of this guidance were reworded to 
improve clarity. The guidance outlines a recommended standardized 
approach (including common conversion factors for calculating human 
equivalent doses) and vocabulary for selecting an MRSD based on animal 
data, and discusses factors to be considered in determining reasonable 
safety margins. This approach is applicable to a first-in-human trial 
of a new drug or biological therapeutic, regardless of intended 
clinical use. The guidance also discusses alternative approaches and 
provides some examples of circumstances under which alternative 
approaches for selection of an MRSD should be considered. Dose 
escalation is not addressed.
    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 estimating the maximum safe starting dose 
in initial clinical trials for therapeutics in adult healthy 
volunteers. 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 guidance at any 
time. 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. The guidance and received 
comments are available for public examination 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 https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14456 Filed 7-21-05; 8:45 am]
BILLING CODE 4160-01-S

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