81_FR_47073 81 FR 46935 - Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards

81 FR 46935 - Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

Page Range46935-46938
FR Document2016-17016

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 the collection of information related to certain 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.

Federal Register, Volume 81 Issue 138 (Tuesday, July 19, 2016) 
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46935-46938]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17016]


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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, 
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 the collection of information 
related to certain 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 September 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0403 for ``Protection of Human Subjects; Informed Consent; 
Institutional Review Boards.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available

[[Page 46936]]

for public viewing and posted on http://www.regulations.gov. Submit 
both copies to the Division of Dockets Management. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20851, [email protected].

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, 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.

Protection of Human Subjects; Informed Consent; Institutional Review 
Boards--21 CFR Parts 50 and 56--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 (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 eight times per year an 
IRB is requested to review emergency research under Sec.  50.24. We 
estimate, of the eight 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), 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

[[Page 46937]]

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 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 21 CFR 
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 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.

[[Page 46938]]

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
56.109(d) Written statement                2,520               2           5,040             0.5           2,520
 about minimal risk research                                                        (30 minutes)
 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 termination           2,520               1           2,520             0.5           1,260
 of IRB approval of research....                                                    (30 minutes)
56.120(a) IRB response to lesser               7               1               7              10              70
 administrative actions for
 noncompliance..................
56.123 Reinstatement of an IRB                 1               1               1               5               5
 or an institution..............
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    1Total......................  ..............  ..............  ..............  ..............         104,679
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR Section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.109(g) IRB written statement about public disclosures to sponsor               8                2               16                1               16
 of emergency research under 50.24.................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17016 Filed 7-18-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices 46935 adjustment provisions with an annual meeting and workshop on a first-come, www.regulations.gov will be posted to operating reserve adjustment to provide first-served basis. the docket unchanged. Because your for adequate carryover resources. Transcripts: As soon as a transcript is comment will be made public, you are available, FDA will post it at http:// solely responsible for ensuring that your J. Impact of PDUFA VI Enhancements www.fda.gov/ForIndustry/UserFees/ comment does not include any on User Fee Revenue confidential information that you or a PrescriptionDrugUserFee/ To implement the proposed ucm446608.htm. third party may not wish to be posted, enhancements for PDUFA VI, funding Dated: July 13, 2016. such as medical information, your or for a cumulative total of 230 FTE staff Leslie Kux, anyone else’s Social Security number, or is proposed to be phased in over the confidential business information, such Associate Commissioner for Policy. course of PDUFA VI. The new funding as a manufacturing process. Please note will be phased in as follows: [FR Doc. 2016–16916 Filed 7–15–16; 4:15 pm] that if you include your name, contact • $20,077,793 for FY 2018 BILLING CODE 4164–01–P information, or other information that • $21,317,472 for FY 2019 identifies you in the body of your • $16,953,329 for FY 2020 comments, that information will be DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov. • $5,426,896 for FY 2021 HUMAN SERVICES • $2,769,609 for FY 2022 • If you want to submit a comment with confidential information that you In addition, $8.73 million will be Food and Drug Administration do not wish to be made available to the added in FY 2018 to provide for other [Docket No. FDA–2013–N–0403] public, submit the comment as a additional direct costs associated with written/paper submission and in the the PDUFA VI enhancements. This Agency Information Collection manner detailed (see ‘‘Written/Paper amount will be included for FYs 2019 Activities; Proposed Collection; Submissions’’ and ‘‘Instructions’’). through 2022 after being adjusted for Comment Request; Protection of inflation. Human Subjects: Informed Consent; Written/Paper Submissions IV. Purpose and Scope of the Meeting Institutional Review Boards Submit written/paper submissions as follows: If you wish to attend this meeting, AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for visit http:// HHS. written/paper submissions): Division of pdufareauthorization.eventbrite.com. ACTION: Notice. Dockets Management (HFA–305), Food Please register by August 8, 2016. If you and Drug Administration, 5630 Fishers are unable to attend the meeting in SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. person, you can register to view a live Administration (FDA) is announcing an • For written/paper comments Webcast of the meeting. You will be opportunity for public comment on the submitted to the Division of Dockets asked to indicate in your registration if proposed collection of certain Management, FDA will post your you plan to attend in person or via the information by the Agency. Under the comment, as well as any attachments, Webcast. Seating will be limited, so Paperwork Reduction Act of 1995 (the except for information submitted, early registration is recommended. PRA), Federal Agencies are required to marked and identified, as confidential, Registration is free and will be on a first- publish notice in the Federal Register if submitted as detailed in come, first-served basis. However, FDA concerning each proposed collection of ‘‘Instructions.’’ may limit the number of participants information, including each proposed Instructions: All submissions received from each organization based on space extension of an existing collection of must include the Docket No. FDA– limitations. Registrants will receive information, and to allow 60 days for 2013–N–0403 for ‘‘Protection of Human confirmation once they have been public comment in response to the Subjects; Informed Consent; accepted. Onsite registration on the day notice. This notice solicits comments on Institutional Review Boards.’’ Received of the meeting will be based on space the collection of information related to comments will be placed in the docket availability. If you need special certain regulations that provide and, except for those submitted as accommodations because of a disability, protection for human subjects of clinical ‘‘Confidential Submissions,’’ publicly please contact Graham Thompson (see investigations conducted in support of viewable at http://www.regulations.gov FOR FURTHER INFORMATION CONTACT) at applications or submissions to FDA for or at the Division of Dockets least 7 days before the meeting. FDA-regulated products. The Management between 9 a.m. and 4 p.m., The meeting will include a regulations provide protection of the Monday through Friday. presentation by FDA and a series of rights, safety, and welfare of human • Confidential Submissions—To invited panels representing different subjects involved in research activities submit a comment with confidential stakeholder groups identified in the within FDA’s jurisdiction. information that you do not wish to be statute (such as patient advocacy DATES: Submit either electronic or made publicly available, submit your groups, consumer advocacy groups, written comments on the collection of comments only as a written/paper health professionals, and regulated information by September 19, 2016. submission. You should submit two industry). We will also provide an ADDRESSES: You may submit comments copies total. One copy will include the opportunity for other organizations and as follows: information you claim to be confidential individuals to make presentations at the with a heading or cover note that states meeting or to submit written comments Electronic Submissions ‘‘THIS DOCUMENT CONTAINS mstockstill on DSK3G9T082PROD with NOTICES to the docket before the meeting. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The FDA will also hold an open public following way: Agency will review this copy, including comment period at the meeting to give • Federal eRulemaking Portal: http:// the claimed confidential information, in the public an opportunity to present www.regulations.gov. Follow the its consideration of comments. The their comments. Registration for open instructions for submitting comments. second copy, which will have the public comment will occur at the Comments submitted electronically, claimed confidential information registration desk on the day of the including attachments, to http:// redacted/blacked out, will be available VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

46936 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices for public viewing and posted on http:// utility; (2) the accuracy of FDA’s of three separate fully convened IRB www.regulations.gov. Submit both estimate of the burden of the proposed meetings to review the request under copies to the Division of Dockets collection of information, including the § 50.24 (one meeting occurring after Management. If you do not wish your validity of the methodology and community consultation). The total name and contact information to be assumptions used; (3) ways to enhance annual reporting burden for IRB review made publicly available, you can the quality, utility, and clarity of the of emergency research under § 50.24 is provide this information on the cover information to be collected; and (4) estimated at 24 hours (see table 1). sheet and not in the body of your ways to minimize the burden of the The information requested in the comments and you must identify this collection of information on regulations for exception from the information as ‘‘confidential.’’ Any respondents, including through the use general requirements for informed information marked as ‘‘confidential’’ of automated collection techniques, consent for medical devices (21 CFR will not be disclosed except in when appropriate, and other forms of 812.47), and the information requested accordance with 21 CFR 10.20 and other information technology. in the regulations for exception from the applicable disclosure law. For more general requirements of informed Protection of Human Subjects; Informed consent in § 50.23, paragraphs (a) information about FDA’s posting of Consent; Institutional Review Boards— comments to public dockets, see 80 FR through (c), and (e), is currently 21 CFR Parts 50 and 56—OMB Control approved under OMB control number 56469, September 18, 2015, or access Number 0910–0755—Extension the information at: http://www.fda.gov/ 0910–0586. The information requested regulatoryinformation/dockets/ Part 50 (21 CFR part 50) applies to all in the investigational new drug (IND) default.htm. clinical investigations regulated by FDA regulations concerning exception from Docket: For access to the docket to under sections 505(i) and 520(g) of the informed consent for emergency read background documents or the Federal Food, Drug, and Cosmetic Act research under § 50.24 is currently electronic and written/paper comments (the FD&C Act) (21 U.S.C. 355(i) and approved under OMB control number received, go to http:// 360j(g), respectively), as well as clinical 0910–0014. In addition, the information www.regulations.gov and insert the investigations that support applications requested in the regulations for IND docket number, found in brackets in the for research or marketing permits for safety reporting requirements for human heading of this document, into the products regulated by FDA, including drug and biological products and safety ‘‘Search’’ box and follow the prompts foods and dietary supplements that bear reporting requirements for and/or go to the Division of Dockets a nutrient content claim or a health bioavailability and bioequivalence Management, 5630 Fishers Lane, Rm. claim, infant formulas, food and color studies in humans (21 CFR 320.31(d), 1061, Rockville, MD 20852. additives, drugs for human use, medical and 21 CFR 312.32(c)(1)(ii) and (iv)) is devices for human use, biological currently approved under OMB control FOR FURTHER INFORMATION CONTACT: FDA products for human use, and electronic number 0910–0672. PRA Staff, Office of Operations, Food products. Compliance with part 50 is Some clinical investigations involving and Drug Administration, Three White intended to protect the rights and safety children, although otherwise not Flint North, 10A63, 11601 Landsdown of subjects involved in investigations approvable, may present an opportunity St., North Bethesda, MD 20851, filed with FDA under sections 403, 406, to understand, prevent, or alleviate a PRAStaff@fda.hhs.gov. 409, 412, 413, 502, 503, 505, 510, 513– serious problem affecting the health or SUPPLEMENTARY INFORMATION: Under the 516, 518–520, 721, and 801 of the FD&C welfare of children (see § 50.54). Certain PRA (44 U.S.C. 3501–3520), Federal Act (21 U.S.C. 343, 346, 348, 350a, 350b, clinical investigations involving Agencies must obtain approval from the 352, 353, 355, 360, 360c–360f, 360h– children may proceed if the IRB finds Office of Management and Budget 360j, 379e, and 381, respectively) and and documents that the clinical (OMB) for each collection of sections 351 and 354–360F of the Public investigation presents a reasonable information they conduct or sponsor. Health Service Act. opportunity to further the ‘‘Collection of information’’ is defined With few exceptions, no investigator understanding, prevention, or in 44 U.S.C. 3502(3) and 5 CFR may involve a human being as a subject alleviation of a serious problem 1320.3(c) and includes Agency requests in FDA-regulated research unless the affecting the health or welfare of or requirements that members of the investigator has obtained the legally children and when the Commissioner of public submit reports, keep records, or effective informed consent of the subject Food and Drugs, after consultation with provide information to a third party. or the subject’s legally authorized a panel of experts in pertinent Section 3506(c)(2)(A) of the PRA (44 representative (see § 50.20 (21 CFR disciplines and following opportunity U.S.C. 3506(c)(2)(A)) requires Federal 50.20)). In seeking informed consent, for public review and comment, makes Agencies to provide a 60-day notice in each subject must be provided with a determination that certain conditions the Federal Register concerning each certain elements of informed consent. are met (see § 50.54(b)). proposed collection of information, Those elements are listed in § 50.25. The information requested for clinical including each proposed extension of an Informed consent shall be documented investigations in children of FDA- existing collection of information, in writing as described in § 50.27. regulated products is covered by the before submitting the collection to OMB An institutional review board (IRB) collections of information in the IND for approval. To comply with this may approve emergency research regulations (part 312 (21 CFR part 312)), requirement, FDA is publishing notice without requiring the informed consent the investigational device exemption of the proposed collection of of all research subjects provided the IRB (IDE) regulations (part 812 (21 CFR part information set forth in this document. finds and documents that certain 812)), the IRB regulations (§ 56.115 (21 mstockstill on DSK3G9T082PROD with NOTICES With respect to the following criteria are met as required in § 50.24. CFR 56.115)), the food additive petition collection of information, FDA invites We estimate that about eight times per and nutrient content claim petition comments on these topics: (1) Whether year an IRB is requested to review regulations (21 CFR 101.69 and 101.70), the proposed collection of information emergency research under § 50.24. We and the infant formula regulations (parts is necessary for the proper performance estimate, of the eight yearly requests for 106 and 107 (21 CFR parts 106 and of FDA’s functions, including whether IRB review under § 50.24, a particular 107)), all of which are approved by the information will have practical IRB will take about an hour during each OMB. Specifically, the information VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices 46937 collected under the IND regulations is This collection of information is a written statement of information that currently approved under OMB control limited to certain provisions in part 50, has been publicly disclosed to the number 0910–0014. The information subpart B (Informed Consent of Human communities in which the investigation collected under the IDE regulations is Subjects), and part 56 (Institutional will be conducted and from which the currently approved under OMB control Review Boards), currently approved subjects will be drawn. Public number 0910–0078. The information under OMB control number 0910–0755. disclosure prior to initiation of the collected under the IRB regulations is This proposed extension applies to investigation would include the plans currently approved under OMB control the following collections of information for the investigation and its risks and number 0910–0130. The information in part 50: §§ 50.24 (Exception from expected benefits. There must also be collected in food additive and nutrient informed consent requirements for public disclosure of sufficient content claim petitions is currently emergency research.), 50.25 (Elements information following completion of the approved under OMB control number of informed consent.), and 50.27 clinical investigation to apprise the 0910–0381 (general requirements) and (Documentation of informed consent.). community and researchers of the 0910–0016 (FDA Form 3503). The In part 56, this proposed extension study, including the demographic information collected under the infant applies to the following collections of characteristics of the research formula regulations is currently information: § 56.109(d) (written population, and its results. (See approved under OMB control number statement about research when § 50.24(a)(7)(ii) and (iii).) The purpose 0910–0256 (general requirements) and documentation of informed consent is of the IRB’s written statements is to 0910–0188 (infant formula recalls). waived); § 56.109(e) (IRB written make the sponsor aware that public Part 56 (21 CFR part 56) contains the notification to approve or disapprove disclosure has occurred, so that the general standards for the composition, research); § 56.109(f) (continuing review sponsor can provide copies of the of research); § 56.109(g) (IRB written information that has been disclosed to operation, and responsibility of an IRB statements to the sponsor about required FDA, as required by 21 CFR 312.54(a) that reviews clinical investigations public disclosures related to emergency and 812.47(a). regulated by FDA under sections 505(i) research under § 50.24); § 56.113 We estimate that about eight requests and 520(g) of the FD&C Act, as well as (Suspension or termination of IRB to review emergency research under clinical investigations that support approval of research.); § 56.120(a) (IRB § 50.24 are submitted each year, and the applications for research or marketing response to lesser administrative actions IRBs that review those studies would permits for products regulated by FDA, for noncompliance); and, § 56.123 prepare two public disclosure reports: including foods and dietary (Reinstatement of an IRB or an One prior to initiation of the research supplements that bear a nutrient content institution.). and one following the study’s claim or a health claim, infant formulas, In § 56.109(d), if an IRB has waived completion. We estimate that it will take food and color additives, drugs for documentation of consent for research an IRB approximately 1 hour to prepare human use, medical devices for human that (1) presents no more than minimal a written statement to the study sponsor use, biological products for human use, risk of harm to subjects and (2) involves describing each public disclosure, for a and electronic products. Compliance no procedures for which consent is total of 2 hours per study. The total with part 56 is intended to protect the normally required outside of the annual third party disclosure burden for rights and welfare of human subjects research context, the IRB may IRBs to fulfill this requirement related to involved in such investigations. nevertheless require the investigator to emergency research under § 50.24 is The information collected under the provide a written statement about the estimated at 16 hours (see table 2). IRB regulations ‘‘Protection of Human research to the subjects. We estimate When an IRB or institution violates Subjects—Recordkeeping and Reporting that each IRB will review about two the regulations, FDA issues to the IRB Requirements for Institutional Review minimal risk FDA-regulated studies or institution a noncompliance letter Boards (part 56),’’ including the each year. Because the studies are (see § 56.120(a)). The IRB or institution information collection activities in the minimal risk, the review can be fairly must respond to the noncompliance provisions in § 56.108(a)(1) and (b), is straightforward, and the written letter describing the corrective actions currently approved under OMB control statement for the subjects would be that will be taken by the IRB or number 0910–0130. The information brief. We estimate that IRB review of institution. FDA estimates about seven collected under the regulations for the each written statement could be IRBs or institutions will be issued a registration of IRBs in § 56.106 is completed in less than 30 minutes (0.5 noncompliance letter annually. We currently approved under OMB control hours). estimate that the IRB’s or institution’s number 0990–0279. The information In § 56.109(f), the amount of time an response will take about 10 hours to collected for IRB review and approval IRB spends on the continuing review of prepare, with an estimated total annual for the IDE regulations (part 812) is a particular study will vary depending burden of 70 hours. currently approved under OMB control on the nature and complexity of the In 2016, FDA disqualified one IRB number 0910–0078. The information research, the amount and type of new under § 56.121. To date, no IRB or collected for premarket approval of information presented to the IRB, and institution has been reinstated or medical devices (part 814 (21 CFR part whether the investigator is seeking applied for reinstatement under 814)) is currently approved under OMB approval of substantive changes to the § 56.123. For this reason, we estimate control number 0910–0231. The research protocol or informed consent the annual reporting burden for one information collected under the document. For many studies, continuing respondent only. We estimate a 5-hour regulations for IRB requirements for review can be fairly straightforward, and burden per response, with an estimated mstockstill on DSK3G9T082PROD with NOTICES humanitarian use devices (part 814, the IRB should be able to complete its total annual burden of 5 hours. subpart H) is currently approved under deliberations and approve the research The regulatory provisions in parts 50 OMB control number 0910–0332. The within a brief period of time. and 56 currently approved under this information collected under the In § 56.109(g), an IRB is required to collection of information, OMB control regulations for IRB review and approval provide the sponsor of a study involving number 0910–0755, and for which this of INDs (part 312) is currently approved an exception from informed consent for extension is requested, are shown in under OMB control number 0910–0014. emergency research under § 50.24 with table 1. VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

46938 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR Section responses per burden per Total hours respondents responses respondent response 56.109(d) Written statement about minimal risk research when documentation of informed consent is waived ....... 2,520 2 5,040 0.5 2,520 (30 minutes) 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 in- formed consent ................................................................. 2,520 40 100,800 1 100,800 50.24 Exception from informed consent requirements for emergency research ......................................................... 8 3 24 1 24 56.113 Suspension or termination of IRB approval of re- search ............................................................................... 2,520 1 2,520 0.5 1,260 (30 minutes) 56.120(a) IRB response to lesser administrative actions for noncompliance ............................................................ 7 1 7 10 70 56.123 Reinstatement of an IRB or an institution ............... 1 1 1 5 5 Total .............................................................................. ........................ ........................ ........................ ........................ 104,679 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 Number of Average Number of disclosures Total annual 21 CFR Section burden per Total hours respondents per disclosures disclosure respondent 56.109(g) IRB written statement about public disclosures to sponsor of emergency research under 50.24 .............. 8 2 16 1 16 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 13, 2016. Questions and Answers’’ (E2C(R2) Q&A Electronic Submissions Leslie Kux, guidance). These guidances were Submit electronic comments in the Associate Commissioner for Policy. prepared under the auspices of the following way: [FR Doc. 2016–17016 Filed 7–18–16; 8:45 am] International Council for Harmonisation • Federal eRulemaking Portal: http:// BILLING CODE 4164–01–P (ICH), formerly the International www.regulations.gov. Follow the Conference on Harmonisation. The instructions for submitting comments. E2C(R2) draft guidance, issued April 11, Comments submitted electronically, DEPARTMENT OF HEALTH AND 2012, updated and combined two ICH including attachments, to http:// HUMAN SERVICES guidances, ‘‘E2C Clinical Safety Data www.regulations.gov will be posted to Management: Periodic Safety Update the docket unchanged. Because your Food and Drug Administration Reports for Marketed Drugs’’ (E2C comment will be made public, you are [Docket No. FDA–2012–D–0315] guidance) and ‘‘Addendum to E2C solely responsible for ensuring that your Clinical Safety Data Management: comment does not include any E2C(R2) Periodic Benefit-Risk Periodic Safety Update Reports for confidential information that you or a Evaluation Report and E2C(R2) Marketed Drugs’’ (addendum to the E2C third party may not wish to be posted, Periodic Benefit-Risk Evaluation guidance). The E2C(R2) guidance is such as medical information, your or Report—Questions and Answers; intended to describe the format, content, anyone else’s Social Security number, or International Council for and timing of a Periodic Benefit-Risk confidential business information, such Harmonisation; Guidances for Evaluation Report (PBRER) for an as a manufacturing process. Please note Industry; Availability approved drug or biologic, and it that if you include your name, contact AGENCY: Food and Drug Administration, finalizes the draft guidance. The information, or other information that HHS. E2C(R2) Q&A guidance is a identifies you in the body of your supplementary guidance that is comments, that information will be ACTION: Notice. intended to clarify key issues in the posted on http://www.regulations.gov. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: The Food and Drug E2C(R2) guidance. • If you want to submit a comment Administration (FDA or Agency) is with confidential information that you DATES: Submit either electronic or announcing the availability of guidances do not wish to be made available to the written comments on Agency guidances for industry entitled ‘‘E2C(R2) Periodic public, submit the comment as a at any time. Benefit-Risk Evaluation’’ (E2C(R2) written/paper submission and in the guidance) and ‘‘E2C(R2) Periodic ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper Benefit-Risk Evaluation Report— as follows: Submissions’’ and ‘‘Instructions’’). 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Document Created: 2016-07-19 01:11:07
Document Modified: 2016-07-19 01:11:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by September 19, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851, [email protected]
FR Citation81 FR 46935 
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