[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76596-76598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26528]


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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.

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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 
December 5, 2016.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0755. 
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, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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 0910-0755--Extension

    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 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 eight times per year an 
IRB is requested to review emergency research under Sec.  50.24. We 
estimate, of the 8 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 24 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 Sec.  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)

[[Page 76597]]

and 21 CFR 312.32(c)(1)(ii) and (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 (Sec.  56.115 (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 (parts 
106 and 107 (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 (Form FDA 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 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 
0990-0279. 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 0910-0014.
    This collection of information is limited to certain provisions in 
part 50, subpart B (Informed Consent of Human Subjects), and part 56 
(Institutional Review Boards), currently approved under OMB control 
number 0910-0755.
    This proposed extension applies to the following collections of 
information in part 50: Sec. Sec.  50.24 (Exception from informed 
consent requirements for emergency research), 50.25 (Elements of 
informed consent), and 50.27 (Documentation of informed consent).
    In part 56, this proposed extension applies to the following 
collections of information: Sec.  56.109(d) (written statement about 
research when documentation of informed consent is waived); Sec.  
56.109(e) (IRB written notification to approve or disapprove research); 
Sec.  56.109(f) (continuing review of research); Sec.  56.109(g) (IRB 
written statements to the sponsor about required public disclosures 
related to emergency research under Sec.  50.24); 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 an 
institution).
    In Sec.  56.109(d), if an IRB has waived documentation of consent 
for research that: (1) Presents no more than minimal risk of harm to 
subjects and (2) involves no procedures for which consent is normally 
required outside of the research context, the IRB may nevertheless 
require the investigator to provide a written statement about the 
research to the subjects. We estimate that each IRB will review about 
two minimal risk FDA-regulated studies each year. Because the studies 
are minimal risk, the review can be fairly straightforward, and the 
written statement for the subjects would be brief. We estimate that IRB 
review of each written statement could be completed in less than 30 
minutes (0.5 hours).
    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.
    In Sec.  56.109(g), an IRB is required to provide the sponsor of a 
study involving an exception from informed consent for emergency 
research under Sec.  50.24 with a written statement of information that 
has been publicly disclosed to the communities in which the 
investigation will be conducted and from which the subjects will be 
drawn. Public disclosure prior to initiation of the investigation would 
include the plans for the investigation and its risks and expected 
benefits. There must also be public disclosure of sufficient 
information following completion of the clinical investigation to 
apprise the community and researchers of the study, including the 
demographic characteristics of the research population, and its 
results. (See Sec.  50.24(a)(7)(ii) and (iii)). The purpose of the 
IRB's written statements is to make the sponsor aware that public 
disclosure has occurred, so that the sponsor can provide copies of the 
information that has been disclosed to FDA, as required by Sec. Sec.  
312.54(a) and 812.47(a).
    We estimate that about eight requests to review emergency research 
under Sec.  50.24 are submitted each year, and the IRBs that review 
those studies would prepare two public disclosure reports: One prior to 
initiation of the research and one following the study's

[[Page 76598]]

completion. We estimate that it will take an IRB approximately 1 hour 
to prepare a written statement to the study sponsor describing each 
public disclosure, for a total of 2 hours per study. The total annual 
third party disclosure burden for IRBs to fulfill this requirement 
related to emergency research under Sec.  50.24 is estimated at 16 
hours (see table 2).
    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 seven 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 70 hours.
    In 2016, FDA disqualified one IRB under Sec.  56.121. To date, no 
IRB or institution has been reinstated or applied for reinstatement 
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.
    The regulatory provisions in parts 50 and 56 currently approved 
under this collection of information, OMB control number 0910-0755, and 
for which this extension is requested, are shown in table 1.
    In the Federal Register of July 19, 2016 (81 FR 46935), 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\
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                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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56.109(d) Written statement              2,520               2           5,040  .5 (30 minutes).           2,520
 about minimal risk research
 when documentation of
 informed consent is waived.
56.109(e) IRB written                    2,520              40         100,800  1...............         100,800
 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                8               3              24  1...............              24
 consent requirements for
 emergency research.
56.113 Suspension or                     2,520               1           2,520  .5 (30 minutes).           1,260
 termination of IRB approval
 of research.
56.120(a) IRB response to                    7               1               7  10..............              70
 lesser administrative actions
 for noncompliance.
56.123 Reinstatement of an IRB               1               1               1  5...............               5
 or an institution.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         104,679
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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56.109(g) IRB written statement about public disclosures to sponsor               8                2               16                1               16
 of emergency research under 50.24.................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26528 Filed 11-2-16; 8:45 am]
 BILLING CODE 4164-01-P