Source: https://www.federalregister.gov/documents/2013/07/23/2013-17550/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2019-10-19 10:21:40
Document Index: 724801472

Matched Legal Cases: ['§\u200950', 'art 312', 'art 312', 'art 812', 'art 812', 'arts 106', 'art 56', 'art 56', 'art 56', 'art 56', '§\u200956', '§\u200956', 'art 812', 'art 814', 'art 814', 'art 814', 'art 312', 'art 56', '§\u200956', '§\u200956', '§\u200956', '§\u200956', '§\u200956']

A Notice by the Food and Drug Administration on 07/23/2013
Fax written comments on the collection of information by August 22, 2013.
78 FR 44126
44126-44128 (3 pages)
Protection of Human Subjects: Informed Consent; Institutional Review Boards—(OMB Control Number 0910-NEW)
https://www.federalregister.gov/d/2013-17550 https://www.federalregister.gov/d/2013-17550
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-NEW and title “Protection of Human Subjects: Informed Consent; Institutional Review Boards.” Also include the FDA docket number found in brackets in the heading of this document.
The information requested in the regulations for exception from the general requirements for informed consent for medical devices (21 CFR 812.47), and the information requested in the regulations for exception from the general requirements of informed consent in 21 CFR 50.23, paragraphs (a) through (c), and (e), is currently approved under OMB control number 0910-0586. The information requested in the investigational new drug (IND) regulations concerning exception from informed consent for emergency research under § 50.24 is currently approved under OMB control number 0910-0014. In addition, the information requested in the regulations for IND safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans (21 CFR 320.31(d) and 312.32(c)(1)(ii) and (c)(1)(iv)) is currently approved under OMB control number 0910-0672.
The information requested for clinical investigations in children of FDA-regulated products is covered by the collections of information in the IND regulations (part 312 (21 CFR part 312)), the investigational device exemption (IDE) regulations (part 812 (21 CFR part 812)), the IRB regulations (21 CFR 56.115), the food additive petition and nutrient content claim petition regulations (21 CFR 101.69 and 101.70), and the infant formula regulations (21 CFR parts 106 and 107)), all of which are approved by OMB. Specifically, the information collected under the IND regulations is currently approved under OMB control number 0910-0014. The information collected under the IDE regulations is currently approved under OMB control number 0910-0078. The information collected under the IRB regulations is currently approved under OMB control number 0910-0130. The information collected in food additive and nutrient content claim petitions is currently approved under OMB control number 0910-0381 (general requirements) and 0910-0016 (FDA Form 3503). The information collected under the infant formula regulations is currently approved under OMB control number 0910-0256 (general requirements) and 0910-0188 (infant formula recalls).
Part 56 (21 CFR part 56) contains the general standards for the composition, operation, and responsibility of an IRB Start Printed Page 44127that reviews clinical investigations regulated by FDA under sections 505(i) and 520(g) of the FD&C Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 56 is intended to protect the rights and welfare of human subjects involved in such investigations.
The information collected under the IRB regulations, “Protection of Human Subjects—Recordkeeping and Reporting Requirements for Institutional Review Boards (part 56),” including the information collection activities in the provisions in § 56.108(a)(1) and (b), is currently approved under OMB control number 0910-0130. The information collected under the regulations for the registration of IRBs in § 56.106 is currently approved under OMB control number 0910-0279. The information collected for IRB review and approval for the IDE regulations (part 812) is currently approved under OMB control number 0910-0078. The information collected for premarket approval of medical devices (part 814 (21 CFR part 814)) is currently approved under OMB control number 0910-0231. The information collected under the regulations for IRB requirements for humanitarian use devices (part 814, subpart H) is currently approved under OMB control number 0910-0332. The information collected under the regulations for IRB review and approval of INDs (part 312) is currently approved under OMB control number OMB control number 0910-0014.
In part 56, those new proposed collections of information are in § 56.109(e) (IRB written notification to approve or disapprove research); § 56.109(f) (continuing review of research); § 56.113 (suspension or termination of IRB approval of research); § 56.120(a) (IRB response to lesser administrative actions for noncompliance); and, § 56.123 (reinstatement of an IRB or institution).
In the Federal Register of April 24, 2013 (78 FR 24208), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
56.109(e) IRB Written Notification to Approve or Disapprove Research; 6,000 40 240,000 1 240,000
56.109(f) Continuing Review; 50.25 Elements of Informed Consent; and
50.27 Documentation of Informed Consent
50.24 Exception from Informed Consent for Emergency Research 5 3 15 1 15
56.113 Suspension or Termination of IRB Approval of Research 6,000 1 6,000 0.5 (30 minutes) 3,000
56.120(a) IRB Response to Lesser Administrative Actions for Noncompliance 5 1 5 10 50
56.123 Reinstatement of an IRB or Institution 1 1 1 5 5
[FR Doc. 2013-17550 Filed 7-22-13; 8:45 am]