80 FR 64422 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 205 (October 23, 2015)

Page Range		64422-64423
FR Document		2015-26985

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 guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

Federal Register, Volume 80 Issue 205 (Friday, October 23, 2015)

[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64422-64423]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26985]



[[Page 64422]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance on Informed Consent for In Vitro Diagnostic 
Device Studies Using Leftover Human Specimens That Are Not Individually 
Identifiable

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 guidance on informed 
consent for in vitro diagnostic device studies using leftover human 
specimens that are not individually identifiable.

DATES: Submit either electronic or written comments on the collection 
of information by December 22, 2015.

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-2012-N-0560 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance on Informed Consent for 
In Vitro Diagnostic Device Studies Using Leftover Human Specimens That 
Are Not Individually Identifiable.'' 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 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

[[Page 64423]]

Guidance on Informed Consent for In Vitro Diagnostic Device Studies 
Using Leftover Human Specimens That Are Not Individually Identifiable--
OMB Control Number 0910-0582--Extension
    FDA's investigational device regulations are intended to encourage 
the development of new, useful devices in a manner that is consistent 
with public health, safety, and compliant with ethical standards. 
Investigators should have freedom to pursue the least burdensome means 
of accomplishing this goal. However, to ensure that the balance is 
maintained between product development and the protection of public 
health, safety, and ethical standards, FDA has established human 
subject protection regulations addressing requirements for informed 
consent and institutional review board (IRB) review that apply to all 
FDA-regulated clinical investigations involving human subjects. In 
particular, informed consent requirements further both safety and 
ethical considerations by allowing potential subjects to consider both 
the physical and privacy risks they face if they agree to participate 
in a trial.
    Under FDA regulations, clinical investigations using human 
specimens conducted in support of premarket submissions to FDA are 
considered human subject investigations (see 21 CFR 812.3(p)). Many 
investigational device studies are exempt from most provisions of part 
812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but 
FDA's regulations for the protection of human subjects (21 CFR parts 50 
and 56) apply to all clinical investigations that are regulated by FDA 
(see 21 CFR 50.1, 21 CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C. 
360j(g)(3)(D)).
    FDA regulations do not contain exceptions from the requirements of 
informed consent on the grounds that the specimens are not identifiable 
or that they are remnants of human specimens collected for routine 
clinical care or analysis that would otherwise have been discarded. Nor 
do FDA regulations allow IRBs to decide whether or not to waive 
informed consent for research involving leftover or unidentifiable 
specimens.
    In a level 1 guidance document, entitled ``Guidance on Informed 
Consent for In Vitro Diagnostic Device Studies Using Leftover Human 
Specimens that are Not Individually Identifiable,'' issued under the 
Good Guidances Practices regulation, 21 CFR 10.115, FDA outlines the 
circumstances in which it intends to exercise enforcement discretion as 
to the informed consent regulations for clinical investigators, 
sponsors, and IRBs.
    The recommendations of the guidance impose a minimal burden on 
industry. FDA estimates that 700 studies will be affected annually. 
Each study will result in one annual record, estimated to take 4 hours 
to complete. This results in a total recordkeeping burden of 2,800 
hours (700 x 4 = 2,800).
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Average  burden
                     FD&C Act section                            No. of        No. of  records      Total annual           per            Total hours
                                                             recordkeepers    per  recordkeeper       records         recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g)...................................................               700                  1                700                  4              2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26985 Filed 10-22-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64423

Guidance on Informed Consent for In consider both the physical and privacy regulations allow IRBs to decide
Vitro Diagnostic Device Studies Using risks they face if they agree to whether or not to waive informed
Leftover Human Specimens That Are participate in a trial. consent for research involving leftover
Not Individually Identifiable—OMB Under FDA regulations, clinical or unidentifiable specimens.
Control Number 0910–0582—Extension investigations using human specimens In a level 1 guidance document,
FDA’s investigational device conducted in support of premarket entitled ‘‘Guidance on Informed
regulations are intended to encourage submissions to FDA are considered Consent for In Vitro Diagnostic Device
the development of new, useful devices human subject investigations (see 21 Studies Using Leftover Human
in a manner that is consistent with CFR 812.3(p)). Many investigational Specimens that are Not Individually
public health, safety, and compliant device studies are exempt from most Identifiable,’’ issued under the Good
with ethical standards. Investigators provisions of part 812, Investigational Guidances Practices regulation, 21 CFR
should have freedom to pursue the least Device Exemptions, under 21 CFR 10.115, FDA outlines the circumstances
burdensome means of accomplishing 812.2(c)(3), but FDA’s regulations for in which it intends to exercise
this goal. However, to ensure that the the protection of human subjects (21 enforcement discretion as to the
balance is maintained between product CFR parts 50 and 56) apply to all informed consent regulations for
development and the protection of clinical investigations that are regulated clinical investigators, sponsors, and
public health, safety, and ethical by FDA (see 21 CFR 50.1, 21 CFR IRBs.
standards, FDA has established human 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 The recommendations of the guidance
subject protection regulations U.S.C. 360j(g)(3)(D)). impose a minimal burden on industry.
addressing requirements for informed FDA regulations do not contain FDA estimates that 700 studies will be
consent and institutional review board exceptions from the requirements of affected annually. Each study will result
(IRB) review that apply to all FDA- informed consent on the grounds that in one annual record, estimated to take
regulated clinical investigations the specimens are not identifiable or 4 hours to complete. This results in a
involving human subjects. In particular, that they are remnants of human total recordkeeping burden of 2,800
informed consent requirements further specimens collected for routine clinical hours (700 × 4 = 2,800).
both safety and ethical considerations care or analysis that would otherwise FDA estimates the burden of this
by allowing potential subjects to have been discarded. Nor do FDA collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of Average
No. of Total annual
FD&C Act section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

520(g) ............................................................... 700 1 700 4 2,800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 15, 2015. and Drug Administration, 8455 DEPARTMENT OF HEALTH AND
Leslie Kux, Colesville Rd., COLE–14526, Silver HUMAN SERVICES
Associate Commissioner for Policy. Spring, MD 20993–0002,
[FR Doc. 2015–26985 Filed 10–22–15; 8:45 am] PRAStaff@fda.hhs.gov. Public Meeting of the Presidential
BILLING CODE 4164–01–P
Commission for the Study of
SUPPLEMENTARY INFORMATION: On June Bioethical Issues
15, 2015, the Agency submitted a
proposed collection of information AGENCY: Presidential Commission for
DEPARTMENT OF HEALTH AND
entitled ‘‘Medical Device Recall the Study of Bioethical Issues, Office of
HUMAN SERVICES
Authority’’ to OMB for review and the Assistant Secretary for Health,
Food and Drug Administration clearance under 44 U.S.C. 3507. An Office of the Secretary, Department of
Health and Human Services.
[Docket No. FDA–2011–N–0793] Agency may not conduct or sponsor,
and a person is not required to respond ACTION: Notice of meeting.
Agency Information Collection to, a collection of information unless it
Activities; Announcement of Office of displays a currently valid OMB control SUMMARY: The Presidential Commission
Management and Budget Approval; number. OMB has now approved the for the Study of Bioethical Issues (the
Medical Device Recall Authority Commission) will conduct its twenty
information collection and has assigned
third meeting on November 17, 2015. At
AGENCY: Food and Drug Administration, OMB control number 0910–0432. The
this meeting, the Commission will
HHS. approval expires on September 30, continue to discuss the role of
2018. A copy of the supporting deliberation and deliberative methods to
ACTION: Notice.
statement for this information collection engage the public and inform
SUMMARY: The Food and Drug is available on the Internet at http:// consideration in bioethics, and how to
Administration (FDA) is announcing www.reginfo.gov/public/do/PRAMain.
mstockstill on DSK4VPTVN1PROD with NOTICES

integrate pubic dialogue into the
that a collection of information entitled Dated: October 15, 2015. bioethics conversation; bioethics
‘‘Medical Device Recall Authority’’ has education as a forum for fostering
Leslie Kux,
been approved by the Office of deliberative skills, and preparing
Management and Budget (OMB) under Associate Commissioner for Policy.
students to participate in public
the Paperwork Reduction Act of 1995. [FR Doc. 2015–26924 Filed 10–22–15; 8:45 am]
dialogue in bioethics; goals and
FOR FURTHER INFORMATION CONTACT: FDA BILLING CODE 4164–01–P methods of bioethics education; and
PRA Staff, Office of Operations, Food integrating bioethics education across a

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by December 22, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 64422

80 FR 64422 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 205 (October 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration