[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24208-24211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the regulations that provide protection for 
human subjects of clinical investigations conducted in support of 
applications or submissions to FDA for FDA-regulated products. The 
regulations provide protection of the rights, safety, and welfare of 
human subjects involved in research activities within FDA's 
jurisdiction.

DATES: Submit either electronic or written comments on the collection 
of information by June 24, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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.

[[Page 24209]]


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: 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 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 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.

Protection of Human Subjects; Informed Consent; Institutional Review 
Boards--21 CFR Parts 50 and 56 (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 21 CFR 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 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) and 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 (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,

[[Page 24210]]

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 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.
    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(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 Termination           6,000               1           6,000             0.5           3,000
 of IRB Approval of Research....                                                    (30 minutes)
56.120(a) IRB Response to Lesser               5               1               5              10              50
 Administrative Actions for
 Noncompliance..................
56.123 Reinstatement of an IRB                 1               1               1               5               5
 or Institution.................
                                                                                                 ---------------
    Total.......................  ..............  ..............  ..............  ..............         243,070
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 24211]]

    Dated: April 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09622 Filed 4-23-13; 8:45 am]
BILLING CODE 4160-01-P