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Draft Guidance for Industry on 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availability of a draft guidance for 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 This draft guidance is 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draft guidance also clarifies FDA’s 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comments on the draft guidance by July 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single copies of the draft guidance to the 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comments on the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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
26640 Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices 

health promotion consumer materials 

related to physical activity and healthy 

eating will be conducted in order to 

assess how the BFWHW materials can 

stimulate a conversation on physical 

activity and healthy eating during a 

clinical encounter, inform future 

BFWHW programming, and add to the 

peer-reviewed literature regarding 

women’s health and wellness 

initiatives. 

Towards this end, anonymous 

assessment forms will be used to collect 

data from young and adult women 

clients, health care providers, and 

administrators of health centers. Data 

collected will include process and 

outcome measures. Data domains 

include: the distribution and use of the 

materials in the health care setting 

during wellness and health 

maintenance/check-up visits; client and 

provider awareness of physical activity 

and nutrition behaviors; attitudes about 

the importance of physical activity and 

nutrition; self-efficacy; and increase in 

knowledge and intent to change 

physical activity and nutrition 

behaviors. 

A total of six organizations, which 

may include Federally Qualified Health 

Centers/Community Health Centers, 

faith-based organizations that offer 

health care services, worksite health 

centers, and school-based health clinics, 

will be selected for the study. Young 

women will complete anonymous 

assessment forms at school-based health 

centers; adult women will be assessed at 

other health care organizations. The 

providers at these sites will also be 

asked to complete a brief one-time 

anonymous assessment form. Telephone 

interviews will be conducted with an 

administrator of each of these sites as 

well. The data collection period at each 

site is estimated to last four months. The 

estimated response burden is as follows: 

Data collection activity 

Estimated Data Collection Burden Hours 

Hourly wage 

rate Total cost Number of 

respondents 

Hours per 

response 

Responses 

per 

respondent 

Total burden 

hours 

Clients .................................................... 3,000 .81 1 2,430 $5.15 $12,514.50 

Administrators ........................................ 6 4 .22 1 25 37.09 927.25 

Support Staff .......................................... 6 63 .67 1 382 13.65 5,214.30 

Providers ................................................ 60 5 .98 1 359 59.15 21,234.85 

Total ................................................ 3,072 .......................... ........................ 3,196 ........................ 39,890.90 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

Karen Matsuoka, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503. 

Dated: May 4, 2007. 

Caroline Lewis, 

Associate Administrator for Management. 

[FR Doc. E7–9011 Filed 5–9–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law (Pub. L.) 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

To request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on 301–443–1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Children’s Hospital 

Graduate Medical Education Payment 

Program (CHGME PP) Annual Report: 

NEW 

The CHGME PP was enacted by Pub. 

L. 106–129 to provide Federal support 

for graduate medical education (GME) to 

freestanding children’s hospitals, 

similar to Medicare GME support 

received by other, non-children’s 

hospitals. The legislation indicates that 

eligible children’s hospitals will receive 

payments for both direct and indirect 

medical education. Direct payments are 

designed to offset the expenses 

associated with operating approved 

graduate medical residency training 

programs and indirect payments are 

designed to compensate hospitals for 

expenses associated with the treatment 

of more severely ill patients and the 

additional costs relating to teaching 

residents in such programs. 

The CHGME PP was reauthorized for 

a period of five years in October 2006 

by Pub. L. 109–307. The reauthorizing 

legislation requires that participating 

children’s hospitals provide information 

about their residency training programs 

in an annual report that will be an 

addendum to the hospitals’ annual 

applications for funds. 

Data are required to be collected on: 

(1) The types of training programs that 

the hospital provided for residents such 

as general pediatrics, internal medicine/ 

pediatrics, and pediatric subspecialties 

including both medical subspecialties 

certified and non-medical 

subspecialties; (2) the number of 

training positions for residents, the 

number of such positions recruited to 

fill, and the number of positions filled; 

(3) the types of training that the hospital 

provided for residents related to the 

health care needs of different 

populations such as children who are 

underserved for reasons of family 

income or geographic location, 

including rural and urban areas; (4) the 

changes in residency training including 

changes in curricula, training 

experiences, and types of training 

programs, and benefits that have 

resulted from such changes and changes 

for purposes of training residents in the 

measurement and improvement and the 

quality and safety of patient care; and 


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