Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; Availability, 65132-65133 [E9-29273]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with NOTICES 65132 Federal Register / Vol. 74, No. 235 / Wednesday, December 9, 2009 / Notices Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.). Maxxam Analytics*, 6740 Campobello Road, Mississauga, ON, Canada L5N 2L8, 905–817–5700, (Formerly: Maxxam Analytics Inc., NOVAMANN (Ontario), Inc.). MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651–636–7466/800–832–3244. MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232, 503–413–5295/800–950–5295. Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612–725– 2088. National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661–322–4250/800–350–3515. One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888–747–3774, (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory). Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800–328–6942, (Formerly: Centinela Hospital Airport Toxicology Laboratory). Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509–755–8991/ 800–541–7891x7. Phamatech, Inc., 10151 Barnes Canyon Road, San Diego, CA 92121, 858–643– 5555. Quest Diagnostics Incorporated, 3175 Presidential Dr., Atlanta, GA 30340, 770–452–1590/800–729–6432, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories). Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403 610–631–4600/877–642–2216, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories). Quest Diagnostics Incorporated, 7600 Tyrone Ave., Van Nuys, CA 91405, 866–370–6699/818–989–2521, (Formerly: SmithKline Beecham Clinical Laboratories). S.E.D. Medical Laboratories, 5601 Office Blvd., Albuquerque, NM 87109, 505– 727–6300/800–999–5227. South Bend Medical Foundation, Inc., 530 N. Lafayette Blvd., South Bend, IN 46601, 574–234–4176 x1276. Southwest Laboratories, 4625 E. Cotton Center Boulevard Suite 177, Phoenix, AZ 85040, 602–438–8507/800–279– 0027. St. Anthony Hospital Toxicology Laboratory, 1000 N. Lee St., VerDate Nov<24>2008 15:02 Dec 08, 2009 Jkt 220001 Oklahoma City, OK 73101, 405–272– 7052. STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800–442–0438. Toxicology & Drug Monitoring Laboratory, University of Missouri Hospital & Clinics, 301 Business Loop 70 West, Suite 208, Columbia, MO 65203, 573–882–1273. Toxicology Testing Service, Inc., 5426 N.W. 79th Ave., Miami, FL 33166, 305–593–2260. US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755– 5235, 301–677–7085. The following laboratory will be voluntarily withdrawing from the National Laboratory Certification Program on December 1, 2009: Clendo Reference Laboratory, Avenue Santa Cruz #58, Bayamon, Puerto Rico 00959, 787–620–9095. —————— *The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 13, 2004 (69 FR 19644). After receiving DOT certification, the laboratory will be included in the monthly list of HHScertified laboratories and participate in the NLCP certification maintenance program. Dated: December 1, 2009. Elaine Parry, Director, Office of Program Services, SAMHSA. [FR Doc. E9–29360 Filed 12–8–09; 8:45 am] BILLING CODE 4160–20–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–D–0362] (Formerly Docket No. 2006–D–0044) Guidance for Industry on PatientReported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; 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 ‘‘Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.’’ This guidance describes how FDA reviews and evaluates patientreported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. This guidance finalizes the draft guidance published on February 3, 2006. 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, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or Office of Communication, Education, and Radiation Programs, Division of Small Manufacturers, International and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850–4307. Send one self-addressed adhesive label to assist 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for E:\FR\FM\09DEN1.SGM 09DEN1 Federal Register / Vol. 74, No. 235 / Wednesday, December 9, 2009 / Notices electronic access to the guidance document. WReier-Aviles on DSKGBLS3C1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Laurie B. Burke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993–0002, 301– 796–0900; 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; or Sahar Dawisha, Center for Devices and Radiological Health (HFZ– 440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–0717. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.’’ This guidance describes how FDA reviews and evaluates PRO instruments used to measure treatment benefit in medical product clinical trials. A PRO instrument (e.g., questionnaire, diary, plus all the information and documentation that support its use) is a means to capture PRO data. This guidance also describes FDA’s current thinking on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. It does not address the use of PRO instruments for purposes beyond evaluation of treatment benefit claims made about a drug or medical product in labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their discussions with FDA during the medical product development process, streamline FDA’s review of PRO instrument adequacy, and provide optimal information about the patient’s perspective for use in making conclusions about treatment benefit at the time of medical product approval. A draft version of this guidance was made available for public comment in the Federal Register of February 3, 2006 (71 FR 5862). All of the public comments we received have been considered and the guidance has been revised as appropriate. 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 the use of PRO measures in medical product clinical trials. It does not create or confer any VerDate Nov<24>2008 15:02 Dec 08, 2009 Jkt 220001 65133 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. The Paperwork Reduction Act of 1995 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. This guidance contains information collection that is 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 information collection has been approved under OMB Control Numbers 0910–0001, 0910–0338, and 0910–0231. The information requested in the guidance is currently submitted to FDA to support the medical product’s effectiveness and to support claims in approved medical product labeling (see 21 CFR 314.50(d)(5), 314.126(b)(6), 601.2, and part 814). 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 https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, https:// www.fda.gov/MedicalDevices/Device RegulationandGuidance/Guidance Documents/default.htm, or https:// www.regulations.gov. Dated: December 3, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–29273 Filed 12–8–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00046 Fmt 4703 National Institutes of Health National Library of Medicine; Notice of Closed Meeting Name of Committee: Biomedical Library and Informatics Review Committee. Date: March 4–5, 2010. Time: March 4, 2010, 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 8600 Rockville Pike, Bethesda, MD 20892. Time: March 5, 2010, 8 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room 8600, Rockville Pike, Bethesda, MD 20892. Contact Person: Arthur A. Petrosian, PhD, Chief Scientific Review Officer, Division of Extramural Programs, National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–496–4253, petrosia@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: December 2, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–29231 Filed 12–8–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Notices]
[Pages 65132-65133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29273]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0362] (Formerly Docket No. 2006-D-0044)


Guidance for Industry on Patient-Reported Outcome Measures: Use 
in Medical Product Development to Support Labeling Claims; 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 ``Patient-Reported 
Outcome Measures: Use in Medical Product Development to Support 
Labeling Claims.'' This guidance describes how FDA reviews and 
evaluates patient-reported outcome (PRO) instruments used to measure 
treatment benefit in medical product clinical trials. It also provides 
recommendations on how sponsors can use study results measured by PRO 
instruments to support claims in approved medical product labeling. 
This guidance finalizes the draft guidance published on February 3, 
2006.

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, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448; or Office of Communication, Education, 
and Radiation Programs, Division of Small Manufacturers, International 
and Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850-4307. Send one self-addressed adhesive label to assist 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.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for

[[Page 65133]]

electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Laurie B. Burke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993-0002, 301-
796-0900; 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; or Sahar Dawisha, Center 
for Devices and Radiological Health (HFZ-440), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0717.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Patient-Reported Outcome Measures: Use in Medical Product 
Development to Support Labeling Claims.'' This guidance describes how 
FDA reviews and evaluates PRO instruments used to measure treatment 
benefit in medical product clinical trials. A PRO instrument (e.g., 
questionnaire, diary, plus all the information and documentation that 
support its use) is a means to capture PRO data. This guidance also 
describes FDA's current thinking on how sponsors can use study results 
measured by PRO instruments to support claims in approved medical 
product labeling. It does not address the use of PRO instruments for 
purposes beyond evaluation of treatment benefit claims made about a 
drug or medical product in labeling.
    By explicitly addressing the review issues identified in this 
guidance, sponsors can increase the efficiency of their discussions 
with FDA during the medical product development process, streamline 
FDA's review of PRO instrument adequacy, and provide optimal 
information about the patient's perspective for use in making 
conclusions about treatment benefit at the time of medical product 
approval.
    A draft version of this guidance was made available for public 
comment in the Federal Register of February 3, 2006 (71 FR 5862). All 
of the public comments we received have been considered and the 
guidance has been revised as appropriate.
    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 the use of PRO measures in medical product 
clinical trials. 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 contains information collection that is 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 information collection 
has been approved under OMB Control Numbers 0910-0001, 0910-0338, and 
0910-0231. The information requested in the guidance is currently 
submitted to FDA to support the medical product's effectiveness and to 
support claims in approved medical product labeling (see 21 CFR 
314.50(d)(5), 314.126(b)(6), 601.2, and part 814).

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 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29273 Filed 12-8-09; 8:45 am]
BILLING CODE 4160-01-S
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