26638 Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). 

There are no other changes to the 

meeting. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: May 7, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–9053 Filed 5–9–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0440] 

Guidance for Industry on 

Computerized Systems Used in 

Clinical Investigations; 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 ‘‘Computerized Systems Used 

in Clinical Investigations,’’ dated May 

2007. This document provides to 

sponsors, contract research 

organizations, data management centers, 

clinical investigators, and institutional 

review boards, recommendations 

regarding the use of computerized 

systems in clinical investigations. 

Because the source data in source 

documentation are necessary for the 

reconstruction and evaluation of the 

trial to determine the safety and 

effectiveness of new human and animal 

drugs, and medical devices, this 

guidance is intended to assist in 

ensuring confidence in the reliability, 

quality, and integrity of electronic 

source data and source documentation, 

i.e., electronic records. This guidance 

supersedes the guidance entitled 

‘‘Computerized Systems Used in 

Clinical Trials,’’ dated April 1999; 

finalizes the draft guidance of the same 

title dated September 2004; and 

supplements the guidance for industry 

entitled ‘‘Part 11, Electronic Records; 

Electronic Signatures—Scope and 

Application,’’ dated August 2003, and 

FDA’s international harmonization 

efforts when applying guidance to 

source data generated at clinical study 

sites. 

DATES: Submit written or electronic 

comments on agency guidance at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Critical Path Programs (HF–

18), Office of the Commissioner, 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 phone requests to 800–835–4709 

or 301–827–1800. 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 http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Patricia M. Beers Block, Good Clinical 

Practice Program (HF–34), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3340. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Computerized Systems Used in 

Clinical Investigations.’’ This document 

provides to sponsors, contract research 

organizations, data management centers, 

clinical investigators, and institutional 

review boards, recommendations 

regarding the use of computerized 

systems in clinical investigations. There 

is an increasing use of computerized 

systems in clinical trials to generate and 

maintain source data and source 

documentation on each clinical trial 

subject. Such source data and source 

documentation must meet certain 

fundamental elements of data quality, 

e.g., attributable, legible, 

contemporaneous, original, and 

accurate, that are expected of paper 

records. FDA’s acceptance of data from 

clinical trials for decisionmaking 

purposes depends on FDA’s ability to 

verify the quality and integrity of the 

data during FDA onsite inspections and 

audits. 

In the Federal Register of October 4, 

2004 (69 FR 59239), FDA announced the 

availability of the draft guidance 

entitled ‘‘Computerized Systems Used 

in Clinical Trials,’’ dated September 

2004. FDA considered the comments 

submitted to the docket in revising this 

guidance. This guidance supersedes the 

guidance of the same title dated April 

1999; finalizes the draft guidance dated 

September 2004; and supplements the 

guidance for industry entitled ‘‘Part 11, 

Electronic Records; Electronic 

Signatures—Scope and Application,’’

dated August 2003, and FDA’s 

international harmonization efforts 

when applying guidance to source data 

generated at clinical study sites. 

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 computerized 

systems used in 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 

requirements of the applicable statutes 

and regulations. 

II. The 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 11 have been approved 

under OMB Control No. 0910–0303. The 

collections of information in 21 CFR 

312.62 have been approved under OMB 

Control No. 0910–0014. The collections 

of information in 21 CFR 511.1(b)(7)(ii) 

have been approved under OMB Control 

No. 0910–0117. The collections of 

information in 21 CFR 812.140 have 

been approved under OMB Control No. 

0910–0078. 

III. Comments 

Interested persons may, at any time, 

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 either 

http://www.fda.gov/oc/gcp or http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices 26639 

Dated: May 4, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9056 Filed 5–9–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0173] 

Draft Guidance for Industry on 

Protecting the Rights, Safety, and 

Welfare of Study Subjects—

Supervisory Responsibilities of 

Investigators; 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 ‘‘Protecting the Rights, 

Safety, and Welfare of Study Subjects—

Supervisory Responsibilities of 

Investigators.’’ This draft guidance is 

intended to assist investigators in 

meeting their responsibilities with 

respect to protecting human subjects 

and ensuring the integrity of data in the 

conduct of clinical investigations. The 

draft guidance also clarifies FDA’s 

expectations concerning the 

investigator’s responsibility for 

supervising a clinical study in which 

some study tasks are delegated to 

employees of the investigator or to 

outside parties. 

DATES: Submit written or electronic 

comments on the draft guidance by July 

9, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Critical Path Programs (HF–

18), Office of the Commissioner, 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 telephone requests to 800–835–

4709 or 301–827–1800. Submit written 

comments on the draft 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 http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Terrie L. Crescenzi, Office of Critical 

Path Programs (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–7864. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Protecting the Rights, Safety, and 

Welfare of Study Subjects—Supervisory 

Responsibilities of Investigators.’’ Under 

the regulations in part 312 (21 CFR part 

312) (Investigational New Drug 

Application) and part 812 (21 CFR part 

812) (Investigational Device 

Exemptions), an investigator is 

responsible for ensuring that a clinical 

investigation is conducted according to 

the signed investigator statement, the 

investigational plan, and applicable 

regulations; for protecting the rights, 

safety, and welfare of subjects under the 

investigator’s care; and for the control of 

drugs, biological products, and devices 

under investigation (§§ 312.60 and 

812.100). This draft guidance clarifies 

the responsibilities of investigators in 

the conduct of clinical investigations 

conducted under parts 312 and 812, 

particularly the responsibilities to 

supervise the conduct of the clinical 

investigation, and to protect the rights, 

safety, and welfare of study participants 

in drug, biologic, and medical device 

clinical trials. The draft guidance also 

provides recommendations on how 

investigators should supervise the 

study-related actions of persons not in 

the direct employ of the investigator, 

including certain study staff and parties 

conducting associated testing and 

assessments. 

This draft guidance is being issued 

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 the supervisory responsibilities of 

investigators. 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 draft 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 part 312 have been 

approved under OMB Control No. 0910–

0014; and the collections of information 

in part 812 have been approved under 

OMB Control No. 0910–0078. 

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 either 

http://www.fda.gov/cder/guidance/ 

index.htm orhttp://www.fda.gov/ohrms/ 

dockets/default.htm. 

Dated: May 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9055 Filed 5–9–07; 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: Women’s Physical 

Activity and Healthy Eating Tools 

Assessment: NEW 

The HRSA Office of Women’s Health 

(OWH) developed the Bright Futures for 

Women’s Health and Wellness 

(BFWHW) Initiative to help expand the 

scope of women’s preventive health 

activities, particularly related to 

nutrition and physical activity. An 

intermediate assessment of the BFWHW 


pwalker on PROD1PC71 with NOTICES