[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41577-41578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
September 3, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collections 
of information to OMB for review and clearance.

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

    When reviewing clinical research studies regulated by FDA, 
institutional review boards (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 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                                
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeper       Records      Recordkeeper                 
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56.115                              2,000              14.6        29,200               4.5       131,400       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Due to a typographical error, the total annual records were 
reported as 10,000 and the hours per recordkeeper were reported as 65 
in a notice issued in the Federal Register of January 27, 1998 (63 FR 
3902), which provided 60 days for public comment on this collection of 
information. The total annual records has been corrected to 29,200 and 
the

[[Page 41578]]

hours per recordkeeper has been corrected to 4.5. 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 (h) 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.
    Two comments were received in response to the January 27, 1998, 
Federal Register notice. Both comments were from major research 
universities and both contended that the estimate of approximately 4.5 
h person-time of recordkeeping burden per meeting was a large 
underestimate.
    One comment asserted that production and distribution of minutes 
took 40 h per meeting, and continual processing of documents received 
and generated by the IRB required 215 h. It is assumed that the latter 
number is calculated on a per month basis, as the comment also refers 
to holding five IRB meetings per month. The IRB reviews approximately 
2,500 active projects, and processes approximately 5,000 required 
documents annually. An unquantified amount of additional time is said 
to be devoted to maintaining member lists, written procedures, and 
forms. The commenting university is among the top 20, or top 1 percent 
of IRB's in terms of the number of investigational new drug (IND) 
studies which it has reviewed. Studies other than those under IND are 
undoubtedly reviewed as well, but the number of IND studies is taken to 
be the best available workload measure. The median number of IND 
studies reviewed by IRB's is approximately 10. Setting aside IRB's 
which have reviewed three or fewer IND studies, which can be considered 
as inactive in reviewing FDA regulated studies, the commenting 
university is still almost at the 99th percentile and the median number 
of IND studies reviewed is 15. If, as assumed, IND workload is directly 
proportional to overall workload across all IRB's, the commenting 
university's workload is 30 times that of the median IRB.
    The second commenting university claimed that 124.5 h were required 
for each meeting. This university is among the top 50 in terms of IND 
studies reviewed, and a similar analysis estimates its workload as 
approximately 21 times that of the median IRB.
    Translating the first commenting university's workload to that of 
the median IRB, the comments indicate a workload of 40 h per meeting 
plus 215 h divided by 5 h continuous activity, or 81 h per meeting. 
Eighty-one hours divided by 30 h equals 2.7 h per meeting of the median 
IRB performing at the same level of efficiency. The second commenting 
university's workload translates to 124.5 h divided by 21 h, or 5.9 h 
per meeting of the median IRB performing at the same efficiency. 
Averaged, these estimated recordkeeping workloads translate to 2.7 h 
plus 5.9 h divided by 2 h, or 4.3 h per meeting.
    This number compares with the FDA's estimate of 4.5 h per meeting 
and supports FDA's estimate, rather than disputing it as the raw 
numbers suggest. It is undeniable that the recordkeeping burden on the 
commenting universities is high, but it is also true that the 
commenting universities have among the busiest IRB's in the nation.

    Dated: July 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20741 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F