Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Recall Authority, 64423 [2015-26924]
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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices
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 FDAregulated 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
64423
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 × 4 = 2,800).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
FD&C Act section
No. of
recordkeepers
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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.
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
[FR Doc. 2015–26985 Filed 10–22–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0793]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Device Recall Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Device Recall Authority’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:05 Oct 22, 2015
On June
15, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Medical Device Recall
Authority’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0432. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Jkt 238001
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26924 Filed 10–22–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues (the
Commission) will conduct its twenty
third meeting on November 17, 2015. At
this meeting, the Commission will
continue to discuss the role of
deliberation and deliberative methods to
engage the public and inform
consideration in bioethics, and how to
integrate pubic dialogue into the
bioethics conversation; bioethics
education as a forum for fostering
deliberative skills, and preparing
students to participate in public
dialogue in bioethics; goals and
methods of bioethics education; and
integrating bioethics education across a
SUMMARY:
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Page 64423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0793]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Medical Device Recall Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Medical Device Recall Authority''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On June 15, 2015, the Agency submitted a
proposed collection of information entitled ``Medical Device Recall
Authority'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0432. The approval
expires on September 30, 2018. A copy of the supporting statement for
this information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26924 Filed 10-22-15; 8:45 am]
BILLING CODE 4164-01-P
