Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; Availability, 9027-9028 [2011-3474]

Download as PDF Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices SUMMARY: Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding human drug products: Judy Staffa, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4447, Silver Spring, MD 20993–0002. Regarding human biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM–17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2011. ADDRESSES: Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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, suite 200N, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.’’ The advent of new technologies and the ability to efficiently assemble electronic healthcare data sets for use in drug safety research have provided many new opportunities for conducting pharmacoepidemiologic studies of product safety issues. These technologies provide the possibility to study safety issues quickly (relative to alternative approaches) in real world health care environments involving large populations of patients. In addition, the application of innovative statistical methods to complex drug safety questions has allowed investigators to study issues previously considered too difficult outside of a clinical trial setting. However, these developments have precipitated a great deal of discussion over the appropriate use of electronic healthcare data and statistical methods in conducting pharmacoepidemiologic safety studies. The primary goals of this draft guidance are to provide the following: • Consistent guidance for industry to use when submitting to FDA reports and protocols for pharmacoepidemiologic safety studies so that study protocols and study reports submitted to FDA contain sufficient information to permit thorough review; • A framework for FDA reviewers to use when reviewing and interpreting these submissions; and • Consistent guidance for FDA to use when conducting these studies. This draft guidance does not address real-time active safety surveillance studies, as this field is still rapidly evolving, and it is not possible at this time to recommend sound best DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; 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 and FDA staff entitled ‘‘Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.’’ The draft guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies using electronic healthcare data sets. The Agency includes recommendations for documenting the design, analysis, and results of such studies and submitting pharmacoepidemiologic safety study protocols and reports to FDA. mstockstill on DSKH9S0YB1PROD with NOTICES DATES: VerDate Mar<15>2010 17:10 Feb 15, 2011 Jkt 223001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 9027 practices. The draft guidance is not intended to be prescriptive with regard to choice of study design or type of analysis and does not endorse any particular type of data resource or methodology. Finally, it does not provide a framework for determining the appropriate weight of evidence of studies from this data stream in the overall assessment of drug safety, as this represents a separate step in the regulatory decisionmaking process and is best accomplished in the context of the specific safety issue under investigation. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agency’s current thinking on the conduct and reporting of pharmacoepidemiologic safety studies using electronic healthcare data. 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) 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. III. Paperwork Reduction Act of 1995 This draft guidance provides best practices for reporting pharmacoepidemiologic safety studies using electronic healthcare data sets. The reports referenced in the draft guidance would be submitted under 21 CFR 314.81, 314.98, and 601.70. These collections of information 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 and are approved under OMB control numbers 0910–0001 and 0910– 0338). IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm,https://www.fda.gov/ BiologicsBloodVaccines/ E:\FR\FM\16FEN1.SGM 16FEN1 9028 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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: GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. Dated: February 9, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–3474 Filed 2–15–11; 8:45 am] BILLING CODE 4160–01–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0520] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products’’ dated January 2011. The guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information that could support an investigational new drug application (IND) or a biologics license application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title dated October 2008. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the 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 the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:10 Feb 15, 2011 Jkt 223001 FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products’’ dated January 2011. The guidance document provides manufacturers of cellular and gene therapy products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information needed to support an IND or a BLA. Because potency measurements are designed specifically for a particular product, the guidance does not make recommendations regarding specific types of potency assays, nor does it propose acceptance criteria for product release. In the Federal Register of October 9, 2008 (73 FR 59635), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes the addition of text related to adjuvant testing and modification of assay parameters for validation studies. In addition, editorial and formatting changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated October 2008. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 part 211 has been approved under 0910–0139; the collections of information in 21 CFR part 312 has been PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 approved under 0910–0014; the collections of information in 21 CFR part 601 has been approved under 0910–0338. 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 guidance at either https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: February 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–3462 Filed 2–15–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0069] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may submit proposed agendas to the Agency by April 18, 2011. FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993–0002, 301– SUMMARY: E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9027-9028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3474]



[[Page 9027]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0057]


Draft Guidance for Industry and Food and Drug Administration 
Staff on Best Practices for Conducting and Reporting 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data 
Sets; 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 and FDA staff entitled 
``Best Practices for Conducting and Reporting Pharmacoepidemiologic 
Safety Studies Using Electronic Healthcare Data Sets.'' The draft 
guidance is intended to describe best practices pertaining to 
conducting and documenting pharmacoepidemiologic safety studies using 
electronic healthcare data sets. The Agency includes recommendations 
for documenting the design, analysis, and results of such studies and 
submitting pharmacoepidemiologic safety study protocols and reports to 
FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)), 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 18, 2011.

ADDRESSES: Submit written requests for single copies of this 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, suite 200N, Rockville, MD 20852-
1448. The draft guidance may also be obtained by mail by calling CBER 
at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 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: Regarding human drug products:

Judy Staffa, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4447, Silver 
Spring, MD 20993-0002.

    Regarding human biological products:

Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration (HFM-17), 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 
and FDA staff entitled ``Best Practices for Conducting and Reporting 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data 
Sets.''
    The advent of new technologies and the ability to efficiently 
assemble electronic healthcare data sets for use in drug safety 
research have provided many new opportunities for conducting 
pharmacoepidemiologic studies of product safety issues. These 
technologies provide the possibility to study safety issues quickly 
(relative to alternative approaches) in real world health care 
environments involving large populations of patients. In addition, the 
application of innovative statistical methods to complex drug safety 
questions has allowed investigators to study issues previously 
considered too difficult outside of a clinical trial setting.
    However, these developments have precipitated a great deal of 
discussion over the appropriate use of electronic healthcare data and 
statistical methods in conducting pharmacoepidemiologic safety studies. 
The primary goals of this draft guidance are to provide the following:
     Consistent guidance for industry to use when submitting to 
FDA reports and protocols for pharmacoepidemiologic safety studies so 
that study protocols and study reports submitted to FDA contain 
sufficient information to permit thorough review;
     A framework for FDA reviewers to use when reviewing and 
interpreting these submissions; and
     Consistent guidance for FDA to use when conducting these 
studies.
    This draft guidance does not address real-time active safety 
surveillance studies, as this field is still rapidly evolving, and it 
is not possible at this time to recommend sound best practices. The 
draft guidance is not intended to be prescriptive with regard to choice 
of study design or type of analysis and does not endorse any particular 
type of data resource or methodology. Finally, it does not provide a 
framework for determining the appropriate weight of evidence of studies 
from this data stream in the overall assessment of drug safety, as this 
represents a separate step in the regulatory decisionmaking process and 
is best accomplished in the context of the specific safety issue under 
investigation.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on the conduct and reporting 
of pharmacoepidemiologic safety studies using electronic healthcare 
data. 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) 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.

III. Paperwork Reduction Act of 1995

    This draft guidance provides best practices for reporting 
pharmacoepidemiologic safety studies using electronic healthcare data 
sets. The reports referenced in the draft guidance would be submitted 
under 21 CFR 314.81, 314.98, and 601.70. These collections of 
information 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 and are approved under OMB control numbers 0910-0001 and 0910-
0338).

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/

[[Page 9028]]

GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3474 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.