01-15405. Agency Information Collection Activities: Proposed Collections; Comment Request

The Department of Health and Human Services, Office of the Secretary will periodically publish summaries of proposed information collections projects and solicit public comments in compliance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. To request more information on the project or to obtain a copy of the information collection plans and instruments, call the OS Reports Clearance Office on [phone].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (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 1. Protection of Human Subjects: Common Rule and HHS Regulations at 45 CFR Part 46-A Common Rule (56 FR 28003) and Department of Health and Human Services regulations (45 CFR part 46) establish common Federal policy for the protection of human subjects of government conducted or sponsored research. The Common Rule, published in 1991, requires applicant and awardee institutions to establish procedures to report, disclose, and keep required records for the protection of human subjects to include informed consent, assurances that an Institutional Review Board has been established, IRB recordkeeping and disclosure requirements, and certification that projects have been reviewed by the IRB. Respondents: Individuals, Business or other for-profit, Non-profit institutions, Federal, State, Local or Tribal Governments.

Burden Estimates

Section of rule and description	Annual No. of responses	Hours per response	Total burden
.103(a), .103(b) and .103(c)—assurances and underlying written policies and procedures	2,100	40	84,000
.103(b)(3)—report change in IRB membership	250	.083	20
.103(b)(5)—report problems, terminations, suspensions	42	8	336
.103(f)—certification	26,600	.083	2,208
.103(b)(4)(i) and .109(d)—IRB disclosure of actions	38,000	1	38,000
.103(b)(4)(ii)—proposed changes reported to IRB	250	.083	20
.103(b)(5)—problems disclosed to IRB and institution	15	8	120
.113—notice of suspension of IRB approval	30	8	240
.116 and .117—informed consent	140,000	.25	35,000
.115(a)—IRB recordkeeping	23,000	1	23,000
Total			182,944

Proposed Project 3. Optional Form 310: Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption—This form may be used by Federal agencies to implement the requirement of the Common Rule which requires that institutions submitting applications for Federal support of research involving human subjects submit certification of appropriate Institutional Review Board review and approval (Section _.103(f) of the Common Rule). The burden associated with this form is included in the table above.

Please send comments to Cynthia Agens Bauer, OS Reports Clearance Officer, Room 503H, Humphrey Building, 200 Independence Avenue SW., Washington DC, 20201. Written comments should be received within 60 days of this notice.

Dated: June 13, 2001.

Kerry Weems,

Acting Deputy Assistant Secretary, Budget.