sroberts on PROD1PC70 with NOTICES

37460 Federal Register / Vol. 73, No. 127 / Tuesday, July 1, 2008 / Notices 

Dated: June 16, 2008. Dated: June 16, 2008. • E-mail: 

John Howard, John Howard, humansubjectstraining@hhs.gov. 

Director, National Institute for Occupational Director, National Institute for Occupational Include ‘‘Human Subjects Protection 

Safety and Health. Safety and Health. Training and Education’’ in the subject 

[FR Doc. E8–14826 Filed 6–30–08; 8:45 am] [FR Doc. E8–14827 Filed 6–30–08; 8:45 am] line. 

• Fax: 301–402–2071. BILLING CODE 4160–17–P BILLING CODE 4160–17–P 

• Mail/Hand delivery/Courier [For 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Designation of a 

Class of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) gives notice of a 

decision to designate a class of 

employees at the Nuclear Materials and 

Equipment Corporation (NUMEC) 

facility, Parks Township, Pennsylvania, 

as an addition to the Special Exposure 

Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. On 

May 30, 2008, the Secretary of HHS 

designated the following class of 

employees as an addition to the SEC: 

All Atomic Weapons Employer (AWE) 

employees who worked at the Nuclear 

Materials and Equipment Corporation 

(NUMEC) facility in Parks Township, 

Pennsylvania, from June 1, 1960, through 

December 31, 1980, for a number of work 

days aggregating at least 250 work days 

occurring either solely under this 

employment or in combination with work 

days within the parameters established for 

one or more other classes of employees in the 

Special Exposure Cohort. 

This designation will become 

effective on June 29, 2008, unless 

Congress provides otherwise prior to the 

effective date. After this effective date, 

HHS will publish a notice in the 

Federal Register reporting the addition 

of this class to the SEC or the result of 

any provision by Congress regarding the 

decision by HHS to add the class to the 

SEC. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information and 

Comments on the Implementation of 

Human Subjects Protection Training 

and Education Programs 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science, 

Office for Human Research Protections. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

Public Health and Science is seeking 

information and comments from 

affected entities and individuals about 

(a) Whether OHRP should issue 

additional guidance recommending that 

institutions engaged in human subjects 

research conducted or supported by the 

Department of Health and Human 

Services (HHS) implement training and 

education programs for certain 

individuals involved in the conduct, 

review, or oversight of human subjects 

research, or (b) whether HHS should 

develop a regulation requiring the 

implementation of such training and 

education programs. This request for 

information and comment stems from 

the 1998 report from the HHS Office of 

Inspector General (OIG) recommending 

that Federal requirements be enacted to 

help ensure that investigators and 

institutional review board (IRB) 

members be adequately educated about, 

and sensitized to, human subjects 

protections. More recently, the 

Secretary’s Advisory Committee on 

Human Research Protections (SACHRP) 

recommended that OHRP require 

institutions to ensure that initial and 

continuing training is provided for IRB 

members and staff, investigators, and 

certain institutional officials. The 

implementation of such training and 

education programs might help to 

ensure that individuals involved in the 

conduct or review of human subjects 

research at institutions holding OHRPapproved Federalwide Assurances 

(FWAs) understand and meet their 

regulatory responsibilities for protecting 

human subjects. 

DATES: Submit written or electronic 

comments by September 29, 2008. 

ADDRESSES: You may submit comments 

by any of the following methods: 

paper, disk, or CD–ROM submissions]: 

Michael A. Carome, M.D., Captain, U.S. 

Public Health Service, OHRP, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received within the public 

comment period, including any 

personal information, will be made 

available to the public upon request. 

FOR FURTHER INFORMATION CONTACT: 

Michael A. Carome, M.D., Captain, U.S. 

Public Health Service, OHRP, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, 240–453–6900; e-mail 

Michael.Carome@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the HHS regulations for the 

protection of human subjects, found at 

45 CFR part 46, institutions or 

organizations that are engaged in human 

subjects research that is conducted or 

supported by HHS must file with OHRP 

an assurance of compliance with the 

human subjects protection regulations. 

The assurance must be executed by an 

individual authorized to act on behalf of 

the institution and authorized to 

assume, on behalf of the institution, the 

obligations imposed by the human 

subjects protection regulations [45 CFR 

46.103(c)]. Thus, to fulfill his or her 

regulatory responsibilities, the 

institutional official must be 

knowledgeable about the requirements 

of the human subjects protection 

regulations. 

The institution’s assurance of 

compliance must also designate one or 

more IRBs to review research covered by 

the regulations, and the institution must 

ensure that each designated IRB has 

sufficient staff to support the IRB’s 

activities [45 CFR 46.103(b)(2)]. IRB 

members must be sufficiently qualified 

through experience and expertise and 

diversity to promote respect for their 

advice and counsel in safeguarding the 

rights and welfare of human subjects. 

IRB members also must have the 

professional competence necessary to 

review human subjects research 

activities of the institution, including 

the ability to ascertain the acceptability 

of the proposed research in terms of 

institutional commitments and 

regulations, applicable law, and 

standards of professional conduct and 

practice; therefore, members must be 

knowledgeable in those areas [45 CFR