79 FR 42 pgs. 12202-12203 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards
Type: NOTICEVolume: 79Number: 42Pages: 12202 - 12203
Pages: 12202, 12203Docket number: [Docket No. FDA-2013-N-1163]
FR document: [FR Doc. 2014-04707 Filed 3-3-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1163]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection of information by April 3, 2014.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0130. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Institutional Review Boards-21 CFR 56.115-(OMB Control Number 0910-0130)-Extension
[top] When reviewing clinical research studies regulated by FDA, institutional review boards (IRBs) 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 that 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
The recordkeeping requirement burden is based on the following: The burden for each of the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. FDA estimates that there are approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times annually. The Agency estimates that approximately 100 hours of person-time per meeting are required to meet the requirements of the regulation.
In the Federal Register of October 1, 2013 (78 FR 60286), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
| 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 56.115 | 2,500 | 14.6 | 36,500 | 100 | 3,650,000 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04707 Filed 3-3-14; 8:45 am]
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