Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens, 21558-21559 [2016-08329]
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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
Research Center. February 11, 2008. (https://
pewhispanic.org/files/reports/85.pdf).
3. Quinlan, J.J. ‘‘Foodborne Illness
Incidence Rates and Food Safety Risks for
Populations of Low Socioeconomic Status
and Minority Race/Ethnicity: A Review of the
Literature.’’ International Journal of
Environmental Research and Public Health
10(8): 3634–3652, 2013.
´
4. Taylor, P., M.H. Lopez, J. Martınez and
G.Velasco. ‘‘Language Use Among Latinos.’’
Pew Research Center. April 4, 2012. (https://
www.pewhispanic.org/2012/04/04/ivlanguage-use-among-latinos/).
5. Henley, S.C., S.E. Stein and J.J. Quinlan.
‘‘Identification of Unique Food Handling
Practices That Could Represent Food Safety
Risks for Minority Consumers.’’ Journal of
Food Protection 75: 2050–2054, 2012.
6. Marin, G., F. Sabogal, B.V. Marin, et al.
‘‘Development of a Short Acculturation Scale
for Hispanics.’’ Hispanic Journal of
Behavioral Sciences 9(2): 183–205, 1987.
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08332 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1101]
EMD Serono; Withdrawal of Approval
of a New Drug Application for LUVERIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of a new drug
application (NDA) for LUVERIS
(lutropin alpha for injection) held by
EMD Serono, One Technology Place,
Rockland, MA 02370. EMD Serono has
voluntarily requested that approval of
this application be withdrawn, thereby
waiving its opportunity for a hearing.
DATES: Effective April 12, 2016.
FOR FURTHER INFORMATION CONTACT:
Emily Helms Williams, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3381.
SUPPLEMENTARY INFORMATION: FDA
approved LUVERIS (lutropin alpha for
injection) on October 8, 2004, under the
Agency’s accelerated approval
regulations, 21 CFR part 314, subpart H.
LUVERIS is indicated for concomitant
administration with GONAL–F
(follitropin alfa for injection) for
stimulation of follicular development in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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infertile hypogonadotropic hypogonadal
women with profound luteinizing
hormone deficiency. In a letter dated
April 30, 2012, EMD Serono requested
that FDA withdraw approval of NDA
021322 for LUVERIS under § 314.150(c).
In that letter, EMD Serono noted that, as
had been previously discussed with the
Agency, it was not feasible to complete
a trial that the company had agreed to
at the time of approval under subpart H.
By letter dated December 8, 2014, FDA
notified EMD Serono that, when studies
that are required as a condition of
approval under the Agency’s accelerated
approval regulations are not completed,
the approval of an application is
withdrawn according to the procedures
set forth in §§ 314.530 and 314.150(d)
rather than under § 314.150(c). FDA
requested that EMD Serono submit a
new withdrawal request under
§ 314.150(d).
Following additional correspondence,
by letter dated July 23, 2015, EMD
Serono requested that FDA withdraw
approval of NDA 021322 for LUVERIS
under § 314.150(d) because a
postmarketing study that was required
as a condition of approval under subpart
H was not completed. Because that
study was required to verify and
describe the clinical benefit of the drug
product, the clinical benefit of LUVERIS
has not been confirmed, and it has not
been established to be safe and effective.
In its July 23, 2015, letter, EMD Serono
waived any opportunity for a hearing
otherwise provided under §§ 314.150
and 314.530. FDA responded by letter
dated September 2, 2015,
acknowledging EMD Serono’s request
that FDA withdraw approval of
LUVERIS under § 314.150(d). FDA also
acknowledged that EMD Serono waived
its opportunity for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner to the
Director, Center for Drug Evaluation and
Research, approval of NDA 021322, and
all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of this product in interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08336 Filed 4–11–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0560]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 12,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0582. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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
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21559
Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
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
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).
In the Federal Register of October 23,
2015 (80 FR 64422), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
The FD&C Act section
Number of
recordkeepers
Number 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: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Phibro Animal Health Corp. may
submit a request for a hearing by May
12, 2016. Submit all data and analysis
upon which the request for a hearing
relies by July 11, 2016.
ADDRESSES: The request for a hearing
may be submitted by Phibro Animal
Health Corp. by either of the following
methods:
Food and Drug Administration
Electronic Submission
DATES:
[FR Doc. 2016–08329 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2016–N–0832]
Phibro Animal Health Corp.; Carbadox
in Medicated Swine Feed; Opportunity
for Hearing
AGENCY:
Food and Drug Administration,
HHS.
Notice of opportunity for
hearing.
ACTION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Written/Paper Submission
The Food and Drug
Administration (FDA), Center for
Veterinary Medicine (CVM), is
proposing to withdraw approval of all
new animal drug applications (NADAs)
providing for use of carbadox in
medicated swine feed. This action is
based on CVM’s determination that the
use of carbadox under the approved
conditions of use results in residues of
carcinogenic concern in the edible
tissues of the treated swine.
SUMMARY:
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• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for hearing. Your
request for a hearing submitted
electronically, including any
attachments to the request for hearing,
to https://www.regulations.gov will be
posted to the docket unchanged.
• Mail/Hand delivery/Courier (for
written/paper request for a hearing):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you may
not wish to be publicly posted, such as
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confidential business information, e.g., a
manufacturing process. The request for
a hearing must include the Docket No.
FDA–2016–N–0832 for ‘‘Phibro Animal
Health Corp.; Carbadox in Medicated
Swine Feed; Opportunity for Hearing.’’
The request for a hearing will be placed
in the docket and publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Phibro Animal Health Corp. may
submit all data and analysis upon which
the request for a hearing relies in the
same manner as the request for a
hearing except as follows:
• Confidential Submissions—To
submit any data and analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analysis. 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 any decisions on
this matter. The second copy, which
will have the claimed confidential
E:\FR\FM\12APN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21558-21559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08329]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0560]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 12,
2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0582.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
[[Page 21559]]
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).
In the Federal Register of October 23, 2015 (80 FR 64422), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
The FD&C Act section Number of records per Total annual per Total hours
recordkeepers 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: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08329 Filed 4-11-16; 8:45 am]
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