Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 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Draft Guidance for Industry and Food 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availability of a draft guidance for 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The draft guidance is intended to 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on the draft guidance by April 18, 2011.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single copies of this draft guidance to 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draft guidance to http:// 

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 http:// 

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm,http://www.fda.gov/

BiologicsBloodVaccines/

mstockstill on DSKH9S0YB1PROD with NOTICES

9028 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

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 

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. 

SUMMARY: 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 http://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: 

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: 

I. Background 

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 

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 http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://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. 

SUMMARY: 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– 

mstockstill on DSKH9S0YB1PROD with NOTICES