Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations; Availability, 7166-7167 [2012-3096]

Download as PDF 7166 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR Section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 810.15(b) .............................................................................. 2 1 1 8 8 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for tables 1 and 2 of this document are based on FDA’s experience with voluntary recalls under part 810 of the regulations. FDA expects no more than two mandatory recalls per year, as most recalls are done voluntarily. Since the last time this collection of information was submitted to OMB for renewal/approval, there has been one mandatory recall. Dated: February 6, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–3098 Filed 2–9–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0096] Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations; Availability AGENCY: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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.’’ This guidance is intended to assist sponsors of clinical investigations in determining the amounts and types of safety data to collect in trials conducted late in the development of a drug for marketing approval or after approval based on what is already known about a drug’s safety profile. Extensive safety data are collected in clinical trials of investigational drugs to support marketing approval (premarket) and trials conducted after approval (postmarket). FDA believes that more selective or targeted safety data collection may be possible for some late stage premarket trials and postmarket trials because certain aspects of a drug’s safety profile will be sufficiently wellestablished that comprehensive data srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 21:29 Feb 09, 2012 Jkt 226001 collection is not needed. FDA believes more selective or targeted safety data collection in appropriate circumstances may improve the quality of the safety assessment without compromising the integrity of the trial results. 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 April 10, 2012. 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 Office of Communication, Outreach and Development (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. 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 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: Lori Bickel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301–796–0210; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Investigations.’’ This guidance is intended to assist clinical trial sponsors in determining the amounts and types of safety data that should be collected during late-stage premarket and postmarket clinical investigations of a drug product based on what is already known about the safety profile of the drug. To meaningfully weigh the risks and benefits of a drug, it is important to collect a broad range of safety-related data and develop a comprehensive safety profile of a drug. In some cases, however, certain aspects of the safety profile may be well-established prior to the completion of clinical trials to support marketing approval of an investigational drug. Similarly, for a marketed drug being studied for a new use, much of the existing safety profile for the approved use may be relevant to the new use. If certain aspects of a safety profile are well-established, it may not be necessary to collect certain types of safety data in clinical trials because the data would not contribute anything additional to the safety profile and may even have negative consequences (e.g., serve as a disincentive to clinical investigators). In those settings, more targeted or selective data collection can be used to focus on collecting data that will further contribute to the safety profile. The draft guidance identifies the types of safety data collected and recommends more selective or targeted safety data collection in a variety of circumstances, offers suggestions on methods that may be used to conduct selective or targeted data collection where appropriate, and highlights circumstances in which comprehensive data collection is generally needed. This draft guidance is being developed 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 determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations. 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 E:\FR\FM\10FEN1.SGM 10FEN1 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices requirements of the applicable statutes and regulations. II. 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. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm or https:// www.regulations.gov. Dated: February 6, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–3096 Filed 2–9–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings srobinson on DSK4SPTVN1PROD with NOTICES 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 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. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel Multi-Center Study of Tamsulosin for Ureteral Stones in the Emergency Department. Date: March 26, 2012. Time: 11 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy VerDate Mar<15>2010 21:29 Feb 09, 2012 Jkt 226001 Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8895, rushingp@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Collaborative Interdisciplinary Team Science in NIDDK Research Areas (R24)—Barrett’s Oesophagus and IBD. Date: March 30, 2012. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Najma Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 749, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; LRP Reviews. Date: March 30, 2012. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: D.G. Patel, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7682, pateldg@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: February 6, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–3153 Filed 2–9–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Global Rare Diseases Patient Registry and Data Repository (GRDR) Notice and Request for Information (RFI) The Office of Rare Diseases Research (ORDR), an organizational component of the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 7167 (NIH), is inviting patient organizations without a patient registry and those with established patient registries to be considered for participation in a twoyear pilot project to establish the Global Rare Diseases Patient Registry and Data Repository (GRDR), and to submit background information about their organization for consideration by the project’s selection committee. More information may be found at https:// rarediseases.info.nih.gov/GRDR. The goal of the GRDR is to enable data analysis within and across many rare diseases and to facilitate clinical trials and other studies. An interface will be developed to accept de-identified patient data from existing patient registries to promote data sharing. The GRDR will serve rare disease patients and their advocacy groups seeking help and information. It will also serve investigators conducting research, clinicians treating patients, epidemiologists analyzing disease data, and investigators seeking patients for new clinical trials and initiating natural history studies. A researcher portal will allow authorized researchers to gain access to de-identified patient data to identify potential study candidates and to learn about the natural history of disease. Because the GRDR will contain only deidentified data, investigators will recruit prospective participants through the patient organizations. Direct contact with the prospective participants would occur only after the patient has granted permission. In order to aggregate data from different registries to facilitate pandisease analysis, data must be captured and collected in a standardized manner. Use of Common Data Elements (CDEs) facilitates the standardization of data collection and allows for harmonization, sharing, and exchange of information across registries. ORDR has developed a set of minimal CDEs that have been accepted and adopted by numerous national and international patient advocacy groups and professional organizations globally. To develop organ systems and disease specific CDEs, ORDR is coordinating and collaborating with the various NIH components, patient advocacy groups, and professional organizations that already have developed similar CDEs or are in the process of developing them. The purpose of this pilot program is to test the different functionalities of the GRDR. A total of 24 organizations will be selected. Twelve organizations with established registries and 12 organizations that have no registry will be chosen to participate. E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7166-7167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3096]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0096]


Draft Guidance for Industry on Determining the Extent of Safety 
Data Collection Needed in Late Stage Premarket and Postapproval 
Clinical Investigations; 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 ``Determining 
the Extent of Safety Data Collection Needed in Late Stage Premarket and 
Postapproval Clinical Investigations.'' This guidance is intended to 
assist sponsors of clinical investigations in determining the amounts 
and types of safety data to collect in trials conducted late in the 
development of a drug for marketing approval or after approval based on 
what is already known about a drug's safety profile. Extensive safety 
data are collected in clinical trials of investigational drugs to 
support marketing approval (premarket) and trials conducted after 
approval (postmarket). FDA believes that more selective or targeted 
safety data collection may be possible for some late stage premarket 
trials and postmarket trials because certain aspects of a drug's safety 
profile will be sufficiently well-established that comprehensive data 
collection is not needed. FDA believes more selective or targeted 
safety data collection in appropriate circumstances may improve the 
quality of the safety assessment without compromising the integrity of 
the trial results.

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 April 10, 2012.

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 
Office of Communication, Outreach and Development (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. 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 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: Lori Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301-796-
0210; or Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Determining the Extent of Safety Data Collection Needed in 
Late Stage Premarket and Postapproval Clinical Investigations.'' This 
guidance is intended to assist clinical trial sponsors in determining 
the amounts and types of safety data that should be collected during 
late-stage premarket and postmarket clinical investigations of a drug 
product based on what is already known about the safety profile of the 
drug.
    To meaningfully weigh the risks and benefits of a drug, it is 
important to collect a broad range of safety-related data and develop a 
comprehensive safety profile of a drug. In some cases, however, certain 
aspects of the safety profile may be well-established prior to the 
completion of clinical trials to support marketing approval of an 
investigational drug. Similarly, for a marketed drug being studied for 
a new use, much of the existing safety profile for the approved use may 
be relevant to the new use. If certain aspects of a safety profile are 
well-established, it may not be necessary to collect certain types of 
safety data in clinical trials because the data would not contribute 
anything additional to the safety profile and may even have negative 
consequences (e.g., serve as a disincentive to clinical investigators). 
In those settings, more targeted or selective data collection can be 
used to focus on collecting data that will further contribute to the 
safety profile.
    The draft guidance identifies the types of safety data collected 
and recommends more selective or targeted safety data collection in a 
variety of circumstances, offers suggestions on methods that may be 
used to conduct selective or targeted data collection where 
appropriate, and highlights circumstances in which comprehensive data 
collection is generally needed.
    This draft guidance is being developed 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 determining 
the extent of safety data collection needed in late stage premarket and 
postapproval clinical investigations. 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

[[Page 7167]]

requirements of the applicable statutes and regulations.

II. 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. 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.

III. Electronic Access

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

    Dated: February 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3096 Filed 2-9-12; 8:45 am]
BILLING CODE 4160-01-P
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