80 FR 64423 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Recall Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		64423-64423
FR Document		2015-26924

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.

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

[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Page 64423]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-26924]

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

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 http://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

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

VerDate Sep<11>2014 18:05 Oct 22, 2015 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1

Document Created: 2015-12-14 15:32:09
Document Modified: 2015-12-14 15:32:09

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.
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 64423

80 FR 64423 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Recall Authority

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