[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Pages 3902-3903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1944]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0535]


Agency Information Collection Activities: Institutional Review 
Boards: Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on FDA's protection of human 
subjects recordkeeping and reporting requirements for institutional 
review boards (IRB's). IRB's are groups composed of members of varying 
backgrounds which are charged with reviewing the ethics and risk/
benefit aspects of clinical studies involving human subjects to assure 
that the rights and welfare of human subjects are adequately protected.

DATES: Submit written comments on the collection of information by 
March 30, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.

[[Page 3903]]

    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Institutional Review Boards--(21 CFR Part 56.115)--(OMB Control 
Number 0910-0130)--Extension

    When reviewing clinical research studies regulated by FDA, IRB's 
are required to create and maintain records describing their 
operations, and make the records available for FDA inspection when 
requested. These records include: (1) Written procedures describing the 
structure and membership of the IRB and the methods which the IRB will 
use in performing its functions; (2) the research protocols, informed 
consent documents, progress reports, and reports of injuries to 
subjects submitted by investigators to the IRB; (3) minutes of meetings 
showing attendance, votes and decisions made by the IRB, the number of 
votes on each decision for, against, and abstaining, the basis for 
requiring changes in or disapproving research; (4) records of 
continuing review activities; (5) copies of all correspondence between 
investigators and the IRB; (6) statements of significant new findings 
provided to subjects of the research; (7) and a list of IRB members by 
name, showing each member's earned degrees, representative capacity, 
and experience in sufficient detail to describe each member's 
contributions to the IRB's deliberations, and any employment 
relationship between each member and the IRB's institution. This 
information is used by the FDA in conducting audit inspections of IRB's 
to determine whether IRB's and clinical investigators are providing 
adequate protections to human subjects participating in clinical 
research.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1.--Estimated Annual Recordkeeping Burden1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
56.115                              2,000              14.6        10,000              65         131,400       
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The recordkeeping requirement burden is based on the following 
formula: Approximately 2,000 IRB's review FDA-regulated research 
involving human subjects annually. The burden for each of the 
paragraphs under 21 CFR 56.115 has been considered as one for purposes 
of estimating the burden. Each paragraph cannot reasonably be 
segregated from one another because all are interrelated. FDA has about 
2,000 IRB's in its inventory. The 2,000 IRB's meet on an average of 
14.6 times annually. The mean number of IRB meetings per year was 
derived from a study conducted by the agency and published by the 
Office of Planning and Evaluation. The agency estimates that 
approximately 4.5 hours of person time per meeting are required to 
transcribe and type the minutes of the meeting, to maintain records of 
continuing review activities, copies of all correspondence between the 
IRB and investigators, member records, and written IRB procedures which 
are approximately five pages per IRB.

    Dated: January 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1944 Filed 1-26-98; 8:45 am]
BILLING CODE 4160-01-F