Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards, 44126-44128 [2013-17550]

Download as PDF 44126 Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices Dated: July 16, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17548 Filed 7–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0403] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 August 22, 2013. 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–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. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@fda.hhs.gov. SUMMARY: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ehiers on DSK2VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Protection of Human Subjects: Informed Consent; Institutional Review Boards— (OMB Control Number 0910–NEW) Part 50 (21 CFR part 50) applies to all clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act VerDate Mar<15>2010 15:40 Jul 22, 2013 Jkt 229001 (the FD&C Act) (21 U.S.C. 355(i) and 360j(g), respectively), 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 50 is intended to protect the rights and safety of subjects involved in investigations filed with the FDA under sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513–516, 518–520, 721, and 801 of the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360, 360c– 360f, 360h–360j, 379e, and 381, respectively) and sections 351 and 354– 360F of the Public Health Service Act. With few exceptions, no investigator may involve a human being as a subject in FDA-regulated research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative (see § 50.20). In seeking informed consent, each subject must be provided with certain elements of informed consent. Those elements are listed in § 50.25. Informed consent shall be documented in writing as described in § 50.27. An institutional review board (IRB) may approve emergency research without requiring the informed consent of all research subjects provided the IRB finds and documents that certain criteria are met as required in § 50.24. We estimate that about five times per year an IRB is requested to review emergency research under § 50.24. We estimate, of the five yearly requests for IRB review under § 50.24, a particular IRB will take about an hour during each of three separate fully convened IRB meetings to review the request under § 50.24 (one meeting occurring after community consultation). The total annual reporting burden for IRB review of emergency research under § 50.24 is estimated at 15 hours (see table 1). 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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. Some clinical investigations involving children, although otherwise not approvable, may present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (see § 50.54). Certain clinical investigations involving children may proceed if the IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and when the Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment, makes a determination that certain conditions are met (see § 50.54(b)). The information requested for clinical investigations in children of FDAregulated 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 E:\FR\FM\23JYN1.SGM 23JYN1 44127 Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices that 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. This new collection of information is limited to certain provisions in part 50, subpart B (informed consent of human subjects), and part 56 (IRBs), not currently approved under the OMB control numbers referenced elsewhere in this document. Those new proposed collections of information in part 50 are §§ 50.24 (emergency research), 50.25 (elements of informed consent), and 50.27 (documentation of informed consent). 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 § 56.109(f), the amount of time an IRB spends on the continuing review of a particular study will vary depending on the nature and complexity of the research, the amount and type of new information presented to the IRB, and whether the investigator is seeking approval of substantive changes to the research protocol or informed consent document. For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time. When an IRB or institution violates the regulations, FDA issues to the IRB or institution a noncompliance letter (see § 56.120(a)). The IRB or institution must respond to the noncompliance letter describing the corrective actions that will be taken by the IRB or institution. FDA estimates about five IRBs or institutions will be issued a noncompliance letter annually. We estimate that the IRB’s or institution’s response will take about 10 hours to prepare, with an estimated total annual burden of 50 hours. To date, no IRB or institution has been disqualified by FDA under § 56.121. Therefore, no IRB or institution has been reinstated under § 56.123. For this reason, we estimate the annual reporting burden for one respondent only. We estimate a 5-hour burden per response, with an estimated total annual burden of 5 hours. Those regulatory provisions in parts 50 and 56 not currently approved under certain OMB control numbers are shown in table 1. 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. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of responses per respondent Number of respondents 21 CFR section 56.109(e) IRB Written Notification to Approve or Disapprove Research; 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 ........................................................................ 56.113 Suspension or Termination of IRB Approval of Research ........................................................................ Total annual responses Average burden per response Total hours 40 240,000 1 240,000 5 3 15 1 15 6,000 1 6,000 0.5 (30 minutes) 3,000 56.120(a) IRB Response to Lesser Administrative Actions for Noncompliance ................................................. 56.123 Reinstatement of an IRB or Institution .................. 5 1 1 1 5 1 10 5 50 5 Total ............................................................................ ehiers on DSK2VPTVN1PROD with NOTICES 6,000 ........................ ........................ ........................ .......................... 243,070 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 16:45 Jul 22, 2013 Jkt 229001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1 44128 Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices Dated: July 16, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17550 Filed 7–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0825] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 requirements for premarket approval of medical devices. DATES: Submit either electronic or written comments on the collection of information by September 23, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, daniel.gittleson@fda.hhs.gov. 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 ehiers on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:40 Jul 22, 2013 Jkt 229001 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 set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (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. Premarket Approval of Medical Devices—21 CFR Part 814 and Federal Food, Drug, and Cosmetic Act Sections 513, 515, and 520 (OMB Control Number 0910–0231)—Extension Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(e)) all devices placed into class III by FDA are subject to premarket approval requirements. Premarket approval (PMA) is the process of scientific and regulatory review to ensure the safety and effectiveness of class III devices. An approved PMA is, in effect, a private license granted to the applicant for marketing a particular medical device. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional class III devices. Manufacturers of class III preamendments devices, devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until 30 months after the issuance of a final classification regulation or until 90 days after the PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 publication of a final regulation requiring the submission of a PMA, whichever period is later. FDA may allow more than 90 days after issuance of a final rule for submission of a PMA. A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices determined by FDA to be substantially equivalent to preamendments class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant’s premarket notification submitted in accordance with section 510(k) of the FD&C Act. Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into class I or II are ‘‘new’’ devices and fall automatically into class III. Before such devices can be marketed, they must have an approved premarket approval application or be must reclassified into class I or class II. The Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 105– 115) was enacted on November 21, 1997, to implement revisions to the FD&C Act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act (21 U.S.C. 360e(d)(6)), which provided that PMA supplements were required for all device changes that affect safety and effectiveness unless such changes are modifications to manufacturing procedures or method of manufacture. That type of manufacturing change will require a 30-day notice, or where FDA finds such notice inadequate, a 135-day PMA supplement. The implementing regulations, contained in 21 CFR part 814, further specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMAs. The regulations’ purpose is to establish an efficient and thorough procedure for FDA’s review of PMAs and supplements to PMAs for class III medical devices. The regulations facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the denial of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval. E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44126-44128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17550]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Protection of Human
Subjects: Informed Consent; 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 August
22, 2013.

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-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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.

Protection of Human Subjects: Informed Consent; Institutional Review
Boards--(OMB Control Number 0910-NEW)

Part 50 (21 CFR part 50) applies to all clinical investigations
regulated by FDA under sections 505(i) and 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g),
respectively), 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 50 is intended to protect the rights and safety of subjects
involved in investigations filed with the FDA under sections 403, 406,
409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of
the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360,
360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and
354-360F of the Public Health Service Act.
With few exceptions, no investigator may involve a human being as a
subject in FDA-regulated research unless the investigator has obtained
the legally effective informed consent of the subject or the subject's
legally authorized representative (see Sec. 50.20). In seeking
informed consent, each subject must be provided with certain elements
of informed consent. Those elements are listed in Sec. 50.25. Informed
consent shall be documented in writing as described in Sec. 50.27.
An institutional review board (IRB) may approve emergency research
without requiring the informed consent of all research subjects
provided the IRB finds and documents that certain criteria are met as
required in Sec. 50.24. We estimate that about five times per year an
IRB is requested to review emergency research under Sec. 50.24. We
estimate, of the five yearly requests for IRB review under Sec. 50.24,
a particular IRB will take about an hour during each of three separate
fully convened IRB meetings to review the request under Sec. 50.24
(one meeting occurring after community consultation). The total annual
reporting burden for IRB review of emergency research under Sec. 50.24
is estimated at 15 hours (see table 1).
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 Sec. 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.
Some clinical investigations involving children, although otherwise
not approvable, may present an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children
(see Sec. 50.54). Certain clinical investigations involving children
may proceed if the IRB finds and documents that the clinical
investigation presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children and when the Commissioner
of Food and Drugs, after consultation with a panel of experts in
pertinent disciplines and following opportunity for public review and
comment, makes a determination that certain conditions are met (see
Sec. 50.54(b)).
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

[[Page 44127]]

that 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 Sec. 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 Sec. 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.
This new collection of information is limited to certain provisions
in part 50, subpart B (informed consent of human subjects), and part 56
(IRBs), not currently approved under the OMB control numbers referenced
elsewhere in this document. Those new proposed collections of
information in part 50 are Sec. Sec. 50.24 (emergency research), 50.25
(elements of informed consent), and 50.27 (documentation of informed
consent).
In part 56, those new proposed collections of information are in
Sec. 56.109(e) (IRB written notification to approve or disapprove
research); Sec. 56.109(f) (continuing review of research); Sec.
56.113 (suspension or termination of IRB approval of research); Sec.
56.120(a) (IRB response to lesser administrative actions for
noncompliance); and, Sec. 56.123 (reinstatement of an IRB or
institution).
In Sec. 56.109(f), the amount of time an IRB spends on the
continuing review of a particular study will vary depending on the
nature and complexity of the research, the amount and type of new
information presented to the IRB, and whether the investigator is
seeking approval of substantive changes to the research protocol or
informed consent document. For many studies, continuing review can be
fairly straightforward, and the IRB should be able to complete its
deliberations and approve the research within a brief period of time.
When an IRB or institution violates the regulations, FDA issues to
the IRB or institution a noncompliance letter (see Sec. 56.120(a)).
The IRB or institution must respond to the noncompliance letter
describing the corrective actions that will be taken by the IRB or
institution. FDA estimates about five IRBs or institutions will be
issued a noncompliance letter annually. We estimate that the IRB's or
institution's response will take about 10 hours to prepare, with an
estimated total annual burden of 50 hours.
To date, no IRB or institution has been disqualified by FDA under
Sec. 56.121. Therefore, no IRB or institution has been reinstated
under Sec. 56.123. For this reason, we estimate the annual reporting
burden for one respondent only. We estimate a 5-hour burden per
response, with an estimated total annual burden of 5 hours.
Those regulatory provisions in parts 50 and 56 not currently
approved under certain OMB control numbers are shown in table 1.
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.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
56.109(e) IRB Written 6,000 40 240,000 1 240,000
Notification to Approve or
Disapprove Research;
56.109(f) Continuing Review;
50.25 Elements of Informed
Consent; and..................
50.27 Documentation of Informed
Consent.......................
50.24 Exception from Informed 5 3 15 1 15
Consent for Emergency Research
56.113 Suspension or 6,000 1 6,000 0.5 3,000
Termination of IRB Approval of (30 minutes)
Research......................
56.120(a) IRB Response to 5 1 5 10 50
Lesser Administrative Actions
for Noncompliance.............
56.123 Reinstatement of an IRB 1 1 1 5 5
or Institution................
��������������������������������
Total...................... .............. .............. .............. ............... 243,070
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 44128]]

Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17550 Filed 7-22-13; 8:45 am]
BILLING CODE 4160-01-P

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